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The Effect of Soliqua on Glucose Variability in Type 2 Patients Among South Asians (VARIATION 2 SA)

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Basal insulin glargine and lixisenatide

Basal insulin Basaglar/Lantus + gliclazide MR

Metformin

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, type 2, GLP-1 RA, Insulin glargine, Glucose variability, Insulin Titration, South Asians

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female adults with clinical diagnosis of T2DM diagnosed at least 1 year before screening and in stable health as assessed by investigator
Age between 18 and 80 years (inclusive)
Body mass index (BMI) between 20-40 kg/m2 (inclusive)
South Asian origin including Afghanistani, Bangladeshi, Indian, Nepali, Pakistani and Sri Lankan. This includes those patients who identify themselves as South Asian origin because their ancestors moved from South Asian to another country (e.g. Caribbean islands, Fiji, etc.)
A1C in range of 7.1-11% (inclusive)
Fasting glucose on self-monitoring of blood glucose (SMBG) or laboratory testing < 15 mmol/L within the last 30 days
Insulin naïve, uncontrolled on oral hypoglycemic medications
Kidney function assessment with eGFR >30 mL/min/1.73 m2
Written informed consent obtained

Exclusion Criteria:

History of insulin use (except emergency short-term use defined as less than 12 weeks for acute illness, hospitalization, pregnancy or with steroid use)
Use of GLP-1 receptor agonist in the past 3 months
Previous discontinuation of a GLP-1 receptor agonist due to safety, tolerability or lack of efficacy
Pregnant or anticipating pregnancy
Current use of steroid
Currently on any supervised, intensive, weight-loss dietary or exercise program
History of gastroparesis with moderate or higher severity
History of pancreatitis
Amylase and /or lipase more than three times the upper limit of normal or calcitonin ≥ 20 pg/mL (5.9 pmol/L)
Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN) syndrome
Allergic reaction to insulin secretagogues
History of weight loss surgery (bariatric bypass surgery or gastric banding)
Inability to check SMBG or wear CGM
History of severe liver disease or alcohol abuse
Severe hypoglycemic reaction (defined as third-party or ambulance assistance or emergency department visit) within the last 3 months before screening visit
Night-shift workers
Patients who are recommended to achieve relaxed targets of A1C up to 8.5% by Diabetes Canada 2018 clinical practice guidelines
Current enrollment in another intervention study
Patients who miss ≥1 injections of Basaglar/Lantus or discontinue the CGM device or can not record carbohydrate intake correctly during the run-in phase

Sites / Locations

LMC Brampton
LMC Etobicoke
LMC Scarborough

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin Glargine + GLP-1 RA

Basaglar/Lantus + gliclazide MR

Arm Description

Insulin Soliqua (a titratable combination of insulin Glargine + GLP-1 RA) will be administered at the subject's end-of run-in phase insulin dose (minimum dose of 15 units in both arms) every morning (before first meal of day) and titrate by one unit per day until fasting glucose level of 4-5.5 mmol/L is obtained, with or without metformin.

Basal insulin Basaglar/Lantus will be administered at the subject's end-of run-in phase insulin dose (minimum dose of 15 units in both arms) every morning (before first meal of day) and titrate by one unit per day until fasting glucose level of 4-5.5 mmol/L is obtained, with gliclazide MR 60 mg OD, with or without metformin.

Outcomes

Primary Outcome Measures

Time in range at week 13

Time with CGM glucose between 4.0 - 10.0 mmol/L within 24 hours over the 7-day CGM period at week 13 after randomization

Time in range within 12-hours (6 AM -6 PM) at week 13

Time with CGM glucose between 4.0 - 10.0 mmol/L within 12-hours (6 AM -6 PM) over the 7-day CGM period at week 13 after randomization

Secondary Outcome Measures

Daily glucose standard deviation (SD) at week 13

Daily SD of CGM glucose over the 7-day CGM period at week 13 after randomization

Overall SD of CGM glucose at week 13

Overall SD of CGM glucose over the 7-day CGM period at week 13 after randomization

Mean of glucose at week 13

Mean of CGM glucose over the 7-day CGM period at week 13 after randomization

Frequency of hypoglycemia at week 13

Number of hypoglycemic event which is defined as CGM glucose <4.0 mmol/L for at least 15 mins (3 consecutive CGM readings) over the 7-day CGM period at week 13 after randomization

Time in hypoglycemia at week 13

Time with CGM glucose < 4.0 mmol/L over the 7-day CGM period at week 13 after randomization

Frequency of hyperglycemia at week 13

Number of hyperglycemic event which is defined as CGM glucose >10.0 mmol/L at least 15 mins (3 consecutive CGM readings) over the 7-day CGM period at week 13 after randomization

Time in hyperglycemia at week 13

Time with CGM glucose >10.0 mmol/L over the 7-day CGM period at week 13 after randomization

Daily glucose standard deviation (SD) within 12 hours (6AM-6PM) at week 13

Daily SD of CGM glucose within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

Overall SD of glucose within 12 hours (6AM-6PM) at week 13

Overall SD of CGM glucose within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

Mean of glucose within 12 hours (6AM-6PM) at week 13

Mean of CGM glucose within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

Frequency of hypoglycemia within 12 hours (6AM-6PM) at week 13

Number of hypoglycemic event which is defined as CGM glucose <4.0 mmol/L for at least 15 mins (3 consecutive CGM readings) within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

Time in hypoglycemia within 12 hours (6AM-6PM) at week 13

Time with CGM glucose <4.0 mmol/L within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

Frequency of hyperglycemia within 12 hours (6AM-6PM) at week 13

Number of hypoglycemic event which is defined as CGM glucose >10.0 mmol/L for at least 15 mins (3 consecutive CGM readings) within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

Time in hyperglycemia within 12 hours (6AM-6PM) at week 13

Time with CGM glucose >10.0 mmol/L within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

A1C mean at week 13

Average of A1C at week 13 after randomization

Changes A1C

A1C value at Visit10 at 13 weeks after randomization minus A1C value at Visit 1 at week -2 (2 weeks before randomization)

Proportion of A1C <7% at week 13

the number of patients who have A1C <7% divided by the total number of patients who have A1C measurement at week 13 after randomization

Proportion of A1C <8% at week 13

the number of patients who have A1C <8% divided by the total number of patients who have A1C measurement at week 13 after randomization

Mean basal insulin dose at week 13

Average of basal insulin dose from patients' diary at week 13 after randomization

Change in weight

Weight difference between week 13 after randomization and baseline at week -2 (2 weeks before randomization) = weight at Visit 10 at week 13 - weight at Visit 1 at week -2.

Change in waist circumference

Waist circumference change between week 13 after randomization and baseline at week -2 (2 week before randomization)= waist circumference at Visit 10 at week 13- waist circumference at Visit 1 at week -2

Change in carbohydrate intake

Carbohydrate intake change between week 13 after randomization and baseline at week -1 = carbohydrate intake at Visit 10 at week 13 - carbohydrate intake at Visit 2 at week -1 (1 week before randomization)

Proportion of patients who have A1C ≤ 7% with no hypoglycemia and no weight gain from baseline

the number of patients who have A1C ≤ 7% with no hypoglycemia and no weight gain from baseline divided by the total number of patients at Week 13 after randomization

Proportion of patients who have A1C ≤ 7% with no hypoglycemia and weight gain <3% from baseline

the number of patients who have A1C ≤ 7% with no hypoglycemia and weight gain <3% from baseline divided by the total number of patients at Week 13 after randomization

Proportion of patients who have fasting blood glucose ≤ 5.5 mmol/L without nocturnal hypoglycemia

the number of patients who have fasting blood glucose ≤ 5.5 mmol/L without nocturnal hypoglycemia divided by the total number of patients at Week 13 after randomization

Change in DiabMedSat Score

DiabMedSat Score will be generated using Diabetes Medication Satisfaction (DiabMedSat) questionnaire. It measures the levels of the subjects' satisfaction with their diabetes medication(s). The range of the score is 0 to 100. The higher the score, the greater the satisfaction. The changes in the score will measure the score difference between Visit 10 at week 13 after randomization and Visit 2 at week -1 (1 week before randomization)

Change in HFS Score

HFS Score will be measured by the Hypoglycemia Fear Survey which assesses the subject's behaviors to avoid hypoglycemia and to measure the subjects' worries about hypoglycemia and its consequences in the past 3 months. The range of the score will be 0 to 132. The higher the score, the greater the fear. The changes will be the score difference between Visit 10 at week 13 after randomization and Visit 2 at week -1 (1 week before randomization).

HCP treatment satisfaction score

HCP treatment satisfaction score will be generated from Healthcare Provider treatment satisfaction questionnaire. It measures the levels of satisfaction of physicians in this study when prescribing this medication at Visit 10 at week 13 after randomization. The range is 0 to 15. The higher the score, the greater the satisfaction.

Full Information

NCT ID

NCT03819790

First Posted

September 24, 2018

Last Updated

February 24, 2021

Sponsor

LMC Diabetes & Endocrinology Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03819790

Brief Title

The Effect of Soliqua on Glucose Variability in Type 2 Patients Among South Asians

Acronym

VARIATION 2 SA

Official Title

Variability of Glucose Assessed in a Randomized Trial Comparing the Initiation of A Treatment Approach With Biosimilar Basal Insulin Analog Or a Titratable iGlarLixi combinatioN in Type 2 Diabetes Among South Asian Subjects (VARIATION 2 SA Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

October 2, 2018 (Actual)

Primary Completion Date

November 19, 2019 (Actual)

Study Completion Date

November 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LMC Diabetes & Endocrinology Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The overall objective of this study is to compare the effects of Soliqua, a titratable combination of insulin and GLP-1 receptor agonist in a single pen versus Glargine U100 insulin (Basaglar or Lantus) and gliclazide MR, both added to metformin, on measures of glucose variability using masked CGM data among people of South Asian origin living in Canada with type 2 diabetes (T2DM).

Detailed Description

The VARIATION 2 SA study is a prospective, open-label, randomized controlled, multi-centre trial to compare the efficacy of two insulin initiation approaches (Soliqua vs Glargine U100 insulin (Basaglar or Lantus) + gliclazide MR) added to maximum tolerated metformin on glucose variability (using masked CGM) in South Asians with T2DM who will initiate insulin therapy with HbA1c of 7.1-11% (inclusive). After giving informed consent and being assessed by eligibility, the patient will stop other oral hypoglycemic agents except metformin (SGLT2 inhibitor may be continued if the patient has cardiovascular diseases history) and enter a 1-week run-in phase with Basaglar or Lantus insulin. During this week (considered as baseline), the patient will: 1) be administered Basaglar or Lantus insulin at an initial dose of 10 units in the morning and increase 1 U/day if fasting glucose >5.5 mmol/L; 2) complete 2 questionnaires to assess the patient-reported outcomes (PROs); 3) wear a masked continuous glucose monitor (CGM) to assess glucose variability; 4) record carbohydrate intake for at least 3 consecutive days. If a patient demonstrates good adherence to Basaglar or Lantus insulin therapy, proper CGM wearing and proper record of carbohydrate intake, and is willing to adhere to insulin treatment will be randomly assigned (1:1) to receive either Soliqua or Glargine U100 insulin (Basaglar or Lantus) + gliclazide MR treatment. The patients will initiate insulin Soliqua or Basaglar/Lantus at their end-of run-in phase insulin dose (minimum dose of 15 units in both arms) every morning (before first meal of day) and titrate by 1 U/day until fasting glucose reaches 4-5.5 mmol/L. In the next 12 weeks, the patients will be optimized their insulin doses via clinic visits or phone calls. They will also be instructed to record their daily fasting glucose, insulin dose, hypoglycemic episodes and any adverse events in a logbook. The primary outcome is to compare the difference of average percentage of Time in Range (4.0-10.0 mmol/L) within 24 hours over the CGM period between two treatments at week 13 after randomization. The co-primary is to compare the difference average percentage of Time in Range (4.0-10.0 mmol/L) within 12 hours (6 AM- 6 PM) over the CGM period between two treatments at week 13 after randomization. The secondary outcomes include the differences on other measurements of glucose variability and patient-reported outcomes (PROs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Diabetes, type 2, GLP-1 RA, Insulin glargine, Glucose variability, Insulin Titration, South Asians

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Patients will be randomized into either of two arms by an interactive system in a 1:1 ratio. Randomization will be stratified based on the use of sodium-glucose co-transporter-2 (SGLT2) inhibitors.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

119 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin Glargine + GLP-1 RA

Arm Type

Experimental

Arm Description

Arm Title

Basaglar/Lantus + gliclazide MR

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Basal insulin glargine and lixisenatide

Intervention Description

Soliqua (insulin glargine and lixisenatide): a titratable combination of long-acting basal insulin glargine and lixisenatide (Glucagon-like peptide-1 receptor agonist)

Intervention Type

Drug

Intervention Name(s)

Basal insulin Basaglar/Lantus + gliclazide MR

Intervention Description

basal long-acting insulin Basaglar/Lantus with gliclazide MR 60 mg OD

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Patients can be administered with most tolerant dose of metformin

Primary Outcome Measure Information:

Title

Time in range at week 13

Description

Time with CGM glucose between 4.0 - 10.0 mmol/L within 24 hours over the 7-day CGM period at week 13 after randomization

Time Frame

7 days

Title

Time in range within 12-hours (6 AM -6 PM) at week 13

Description

Time with CGM glucose between 4.0 - 10.0 mmol/L within 12-hours (6 AM -6 PM) over the 7-day CGM period at week 13 after randomization

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Daily glucose standard deviation (SD) at week 13

Description

Daily SD of CGM glucose over the 7-day CGM period at week 13 after randomization

Time Frame

7 days

Title

Overall SD of CGM glucose at week 13

Description

Overall SD of CGM glucose over the 7-day CGM period at week 13 after randomization

Time Frame

7 days

Title

Mean of glucose at week 13

Description

Mean of CGM glucose over the 7-day CGM period at week 13 after randomization

Time Frame

7 days

Title

Frequency of hypoglycemia at week 13

Description

Number of hypoglycemic event which is defined as CGM glucose <4.0 mmol/L for at least 15 mins (3 consecutive CGM readings) over the 7-day CGM period at week 13 after randomization

Time Frame

7 days

Title

Time in hypoglycemia at week 13

Description

Time with CGM glucose < 4.0 mmol/L over the 7-day CGM period at week 13 after randomization

Time Frame

7 days

Title

Frequency of hyperglycemia at week 13

Description

Number of hyperglycemic event which is defined as CGM glucose >10.0 mmol/L at least 15 mins (3 consecutive CGM readings) over the 7-day CGM period at week 13 after randomization

Time Frame

7 days

Title

Time in hyperglycemia at week 13

Description

Time with CGM glucose >10.0 mmol/L over the 7-day CGM period at week 13 after randomization

Time Frame

7 days

Title

Daily glucose standard deviation (SD) within 12 hours (6AM-6PM) at week 13

Description

Daily SD of CGM glucose within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

Time Frame

7 days

Title

Overall SD of glucose within 12 hours (6AM-6PM) at week 13

Description

Overall SD of CGM glucose within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

Time Frame

7 days

Title

Mean of glucose within 12 hours (6AM-6PM) at week 13

Description

Mean of CGM glucose within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

Time Frame

7 days

Title

Frequency of hypoglycemia within 12 hours (6AM-6PM) at week 13

Description

Time Frame

7 days

Title

Time in hypoglycemia within 12 hours (6AM-6PM) at week 13

Description

Time with CGM glucose <4.0 mmol/L within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

Time Frame

7 days

Title

Frequency of hyperglycemia within 12 hours (6AM-6PM) at week 13

Description

Time Frame

7 days

Title

Time in hyperglycemia within 12 hours (6AM-6PM) at week 13

Description

Time with CGM glucose >10.0 mmol/L within 12 hours (6AM-6PM) over the 7-day CGM period at week 13 after randomization

Time Frame

7 days

Title

A1C mean at week 13

Description

Average of A1C at week 13 after randomization

Time Frame

Week 13

Title

Changes A1C

Description

A1C value at Visit10 at 13 weeks after randomization minus A1C value at Visit 1 at week -2 (2 weeks before randomization)

Time Frame

15 weeks

Title

Proportion of A1C <7% at week 13

Description

the number of patients who have A1C <7% divided by the total number of patients who have A1C measurement at week 13 after randomization

Time Frame

Week 13

Title

Proportion of A1C <8% at week 13

Description

the number of patients who have A1C <8% divided by the total number of patients who have A1C measurement at week 13 after randomization

Time Frame

Week 13

Title

Mean basal insulin dose at week 13

Description

Average of basal insulin dose from patients' diary at week 13 after randomization

Time Frame

Week 13

Title

Change in weight

Description

Weight difference between week 13 after randomization and baseline at week -2 (2 weeks before randomization) = weight at Visit 10 at week 13 - weight at Visit 1 at week -2.

Time Frame

15 weeks

Title

Change in waist circumference

Description

Time Frame

15 weeks

Title

Change in carbohydrate intake

Description

Time Frame

14 weeks

Title

Proportion of patients who have A1C ≤ 7% with no hypoglycemia and no weight gain from baseline

Description

the number of patients who have A1C ≤ 7% with no hypoglycemia and no weight gain from baseline divided by the total number of patients at Week 13 after randomization

Time Frame

Week 13

Title

Proportion of patients who have A1C ≤ 7% with no hypoglycemia and weight gain <3% from baseline

Description

the number of patients who have A1C ≤ 7% with no hypoglycemia and weight gain <3% from baseline divided by the total number of patients at Week 13 after randomization

Time Frame

Week 13

Title

Proportion of patients who have fasting blood glucose ≤ 5.5 mmol/L without nocturnal hypoglycemia

Description

the number of patients who have fasting blood glucose ≤ 5.5 mmol/L without nocturnal hypoglycemia divided by the total number of patients at Week 13 after randomization

Time Frame

Week 13

Title

Change in DiabMedSat Score

Description

Time Frame

14 weeks

Title

Change in HFS Score

Description

Time Frame

14 weeks

Title

HCP treatment satisfaction score

Description

Time Frame

Week 13

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female adults with clinical diagnosis of T2DM diagnosed at least 1 year before screening and in stable health as assessed by investigator Age between 18 and 80 years (inclusive) Body mass index (BMI) between 20-40 kg/m2 (inclusive) South Asian origin including Afghanistani, Bangladeshi, Indian, Nepali, Pakistani and Sri Lankan. This includes those patients who identify themselves as South Asian origin because their ancestors moved from South Asian to another country (e.g. Caribbean islands, Fiji, etc.) A1C in range of 7.1-11% (inclusive) Fasting glucose on self-monitoring of blood glucose (SMBG) or laboratory testing < 15 mmol/L within the last 30 days Insulin naïve, uncontrolled on oral hypoglycemic medications Kidney function assessment with eGFR >30 mL/min/1.73 m2 Written informed consent obtained Exclusion Criteria: History of insulin use (except emergency short-term use defined as less than 12 weeks for acute illness, hospitalization, pregnancy or with steroid use) Use of GLP-1 receptor agonist in the past 3 months Previous discontinuation of a GLP-1 receptor agonist due to safety, tolerability or lack of efficacy Pregnant or anticipating pregnancy Current use of steroid Currently on any supervised, intensive, weight-loss dietary or exercise program History of gastroparesis with moderate or higher severity History of pancreatitis Amylase and /or lipase more than three times the upper limit of normal or calcitonin ≥ 20 pg/mL (5.9 pmol/L) Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN) syndrome Allergic reaction to insulin secretagogues History of weight loss surgery (bariatric bypass surgery or gastric banding) Inability to check SMBG or wear CGM History of severe liver disease or alcohol abuse Severe hypoglycemic reaction (defined as third-party or ambulance assistance or emergency department visit) within the last 3 months before screening visit Night-shift workers Patients who are recommended to achieve relaxed targets of A1C up to 8.5% by Diabetes Canada 2018 clinical practice guidelines Current enrollment in another intervention study Patients who miss ≥1 injections of Basaglar/Lantus or discontinue the CGM device or can not record carbohydrate intake correctly during the run-in phase

Facility Information:

Facility Name

LMC Brampton

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6S 0C9

Country

Canada

Facility Name

LMC Etobicoke

City

Etobicoke

State/Province

Ontario

Country

Canada

Facility Name

LMC Scarborough

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M1R 0B1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

9742976

Citation

Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum In: Lancet 1999 Aug 14;354(9178):602.

Results Reference

background

PubMed Identifier

27659408

Citation

Lipska KJ, Yao X, Herrin J, McCoy RG, Ross JS, Steinman MA, Inzucchi SE, Gill TM, Krumholz HM, Shah ND. Trends in Drug Utilization, Glycemic Control, and Rates of Severe Hypoglycemia, 2006-2013. Diabetes Care. 2017 Apr;40(4):468-475. doi: 10.2337/dc16-0985. Epub 2016 Sep 22.

Results Reference

background

PubMed Identifier

24428469

Citation

Tobias DK, Pan A, Jackson CL, O'Reilly EJ, Ding EL, Willett WC, Manson JE, Hu FB. Body-mass index and mortality among adults with incident type 2 diabetes. N Engl J Med. 2014 Jan 16;370(3):233-44. doi: 10.1056/NEJMoa1304501. Erratum In: N Engl J Med. 2014 Apr 3;370(14):1368.

Results Reference

background

PubMed Identifier

24731666

Citation

Scheen AJ, Van Gaal LF. Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes. Lancet Diabetes Endocrinol. 2014 Nov;2(11):911-22. doi: 10.1016/S2213-8587(14)70004-X. Epub 2014 Feb 19.

Results Reference

background

PubMed Identifier

15331551

Citation

Degn KB, Brock B, Juhl CB, Djurhuus CB, Grubert J, Kim D, Han J, Taylor K, Fineman M, Schmitz O. Effect of intravenous infusion of exenatide (synthetic exendin-4) on glucose-dependent insulin secretion and counterregulation during hypoglycemia. Diabetes. 2004 Sep;53(9):2397-403. doi: 10.2337/diabetes.53.9.2397.

Results Reference

background

PubMed Identifier

15111485

Citation

Degn KB, Juhl CB, Sturis J, Jakobsen G, Brock B, Chandramouli V, Rungby J, Landau BR, Schmitz O. One week's treatment with the long-acting glucagon-like peptide 1 derivative liraglutide (NN2211) markedly improves 24-h glycemia and alpha- and beta-cell function and reduces endogenous glucose release in patients with type 2 diabetes. Diabetes. 2004 May;53(5):1187-94. doi: 10.2337/diabetes.53.5.1187.

Results Reference

background

PubMed Identifier

9449682

Citation

Flint A, Raben A, Astrup A, Holst JJ. Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans. J Clin Invest. 1998 Feb 1;101(3):515-20. doi: 10.1172/JCI990.

Results Reference

background

PubMed Identifier

28724168

Citation

Leiter LA, Nauck MA. Efficacy and Safety of GLP-1 Receptor Agonists Across the Spectrum of Type 2 Diabetes Mellitus. Exp Clin Endocrinol Diabetes. 2017 Jul;125(7):419-435. doi: 10.1055/s-0043-103969. Epub 2017 Jul 19. German.

Results Reference

background

PubMed Identifier

26642233

Citation

Zaccardi F, Htike ZZ, Webb DR, Khunti K, Davies MJ. Benefits and Harms of Once-Weekly Glucagon-like Peptide-1 Receptor Agonist Treatments: A Systematic Review and Network Meta-analysis. Ann Intern Med. 2016 Jan 19;164(2):102-13. doi: 10.7326/M15-1432. Epub 2015 Dec 8.

Results Reference

background

PubMed Identifier

24898300

Citation

Rosenstock J, Fonseca VA, Gross JL, Ratner RE, Ahren B, Chow FC, Yang F, Miller D, Johnson SL, Stewart MW, Leiter LA; Harmony 6 Study Group. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Diabetes Care. 2014 Aug;37(8):2317-25. doi: 10.2337/dc14-0001. Epub 2014 Jun 4.

Results Reference

background

PubMed Identifier

25011946

Citation

Diamant M, Nauck MA, Shaginian R, Malone JK, Cleall S, Reaney M, de Vries D, Hoogwerf BJ, MacConell L, Wolffenbuttel BH; 4B Study Group. Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care. 2014 Oct;37(10):2763-73. doi: 10.2337/dc14-0876. Epub 2014 Jul 10.

Results Reference

background

PubMed Identifier

25562265

Citation

Writing Group for the DCCT/EDIC Research Group; Orchard TJ, Nathan DM, Zinman B, Cleary P, Brillon D, Backlund JY, Lachin JM. Association between 7 years of intensive treatment of type 1 diabetes and long-term mortality. JAMA. 2015 Jan 6;313(1):45-53. doi: 10.1001/jama.2014.16107.

Results Reference

background

PubMed Identifier

18784090

Citation

Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10.

Results Reference

background

PubMed Identifier

25409370

Citation

Lind M, Svensson AM, Kosiborod M, Gudbjornsdottir S, Pivodic A, Wedel H, Dahlqvist S, Clements M, Rosengren A. Glycemic control and excess mortality in type 1 diabetes. N Engl J Med. 2014 Nov 20;371(21):1972-82. doi: 10.1056/NEJMoa1408214.

Results Reference

background

PubMed Identifier

15197140

Citation

Esposito K, Giugliano D, Nappo F, Marfella R; Campanian Postprandial Hyperglycemia Study Group. Regression of carotid atherosclerosis by control of postprandial hyperglycemia in type 2 diabetes mellitus. Circulation. 2004 Jul 13;110(2):214-9. doi: 10.1161/01.CIR.0000134501.57864.66. Epub 2004 Jun 14.

Results Reference

background

PubMed Identifier

18650371

Citation

Kilpatrick ES, Rigby AS, Atkin SL. A1C variability and the risk of microvascular complications in type 1 diabetes: data from the Diabetes Control and Complications Trial. Diabetes Care. 2008 Nov;31(11):2198-202. doi: 10.2337/dc08-0864. Epub 2008 Jul 23.

Results Reference

background

PubMed Identifier

27913575

Citation

Bajaj HS, Venn K, Ye C, Patrick A, Kalra S, Khandwala H, Aslam N, Twum-Barima D, Aronson R. Lowest Glucose Variability and Hypoglycemia Are Observed With the Combination of a GLP-1 Receptor Agonist and Basal Insulin (VARIATION Study). Diabetes Care. 2017 Feb;40(2):194-200. doi: 10.2337/dc16-1582. Epub 2016 Dec 2.

Results Reference

background

PubMed Identifier

20403888

Citation

Chiu M, Austin PC, Manuel DG, Tu JV. Comparison of cardiovascular risk profiles among ethnic groups using population health surveys between 1996 and 2007. CMAJ. 2010 May 18;182(8):E301-10. doi: 10.1503/cmaj.091676. Epub 2010 Apr 19.

Results Reference

background

PubMed Identifier

26260346

Citation

Chiu M, Maclagan LC, Tu JV, Shah BR. Temporal trends in cardiovascular disease risk factors among white, South Asian, Chinese and black groups in Ontario, Canada, 2001 to 2012: a population-based study. BMJ Open. 2015 Aug 10;5(8):e007232. doi: 10.1136/bmjopen-2014-007232.

Results Reference

background

PubMed Identifier

23317344

Citation

Gujral UP, Pradeepa R, Weber MB, Narayan KM, Mohan V. Type 2 diabetes in South Asians: similarities and differences with white Caucasian and other populations. Ann N Y Acad Sci. 2013 Apr;1281(1):51-63. doi: 10.1111/j.1749-6632.2012.06838.x. Epub 2013 Jan 14.

Results Reference

background

PubMed Identifier

28803820

Citation

Yale JF, Berard L, Groleau M, Javadi P, Stewart J, Harris SB. TITRATION: A Randomized Study to Assess 2 Treatment Algorithms with New Insulin Glargine 300 units/mL. Can J Diabetes. 2017 Oct;41(5):478-484. doi: 10.1016/j.jcjd.2017.06.007. Epub 2017 Aug 10.

Results Reference

background

PubMed Identifier

35752566

Citation

Bajaj HS, Chu L, Bansal N, Brown RE, Dhillon G, Gupta R, Bhela JS, Padda JK, Khandwala H, Venn K, Aronson R. Randomized Comparison of Initiating the Fixed-Ratio Combination of iGlarLixi or Biosimilar Insulin Glargine Together With Gliclazide in Participants of South Asian Origin With Type 2 Diabetes: VARIATION 2 SA Trial. Can J Diabetes. 2022 Jul;46(5):495-502. doi: 10.1016/j.jcjd.2022.02.003. Epub 2022 Feb 11.

Results Reference

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The Effect of Soliqua on Glucose Variability in Type 2 Patients Among South Asians

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