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Effects of Sequential Treatment Based on Lina/MET After Short-term Intensive Insulin in Newly Diagnosed Type 2 Diabetes

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
CSII followed by Lina+MET
CSII followed by Lina
CSII followed by MET
CSII alone
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes mellitus, Continuous subcutaneous insulin infusion, Metformin, Linagliptin

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with type 2 diabetes who have never received any hypoglycemic treatment, or patients with type 2 diabetes <1 year from diagnosis who have used no more than 1 type of hypoglycemic drug for no more than 1 week and discontinued for more than 4 weeks before enrollment;
  2. Fasting plasma glucose (FPG) between 7.0 mmol/l (126 mg/dl) and 16.7 mmol/l (300 mg/dl); glycosylated hemoglobin A1C>8.5%;
  3. Aged between 25 and 65 years, body mass index (BMI) 22-35 kg/m2.

Exclusion Criteria:

  1. Type 1 diabetes or special type of diabetes;
  2. Acute complications of diabetes (including DKA, HHS and lactic acidosis)
  3. Serious microvascular complications: proliferative stage of retinopathy; urine AER >300 mg/g or urine protein positive, quantification >0.5 g/d; uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy;
  4. Severe macrovascular complications: acute cerebrovascular accident, acute coronary syndrome, vascular intervention for peripheral arterial disease or amputation requiring hospitalization within 12 months prior to enrollment;
  5. Persistently increased blood pressure >180/110 mmHg;
  6. Blood creatinine clearance less than 50 ml/min, alanine aminotransferase ≥2.5×upper limit of normal, total bilirubin ≥1.5×upper limit of normal;
  7. Hemoglobin <100 g/L or need regular blood transfusion;
  8. Use of drugs that may influence blood glucose within 12 weeks;
  9. Systemic infection or serious concomitant disease; patients with malignancy or chronic diarrhea;
  10. Uncontrolled endocrine gland dysfunction;
  11. Patients with mental or communication disorders;
  12. Chronic cardiac insufficiency, heart function class III and above;
  13. Pregnant women, lactating women and women of child bearing age who are not willing to take contraception during the study;
  14. Subjects who don't cooperate, cannot be followed up or have difficulty in completing the study considered by the investigator.

Sites / Locations

  • endocrinology department of the first affiliated hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Linagliptin plus metformin

Linagliptin

Metformin

Lifestyle alone

Arm Description

CSII followed by Linagliptin 5 mg Qd + Metformin 0.5 g bid for 48 weeks

CSII followed by Linagliptin 5mg Qd for 48 weeks

CSII followed by Metformin 0.5 bid for 48 weeks

No OHA is given after CSII

Outcomes

Primary Outcome Measures

proportion of subjects with optimal glycemic control
proportion of patients achieving glycosylated hemoglobin A1C <7% at the end of sequential treatment in each treatment group.

Secondary Outcome Measures

proportion of subjects with excellent glycemic control
proportion of patients achieving glycosylated hemoglobin A1C <6.5% at the end of sequential treatment in each treatment group.
Change of β cell function
Differences in β-cell indicators among treatment arms at the end of study.
Change of insulin sensitivity
Differences in insulin sensitivity indicators among treatment arms at the end of study.
Incidence of adverse events
Differences in incidence of adverse events among treatment arms at the end of study.

Full Information

First Posted
June 19, 2017
Last Updated
April 28, 2021
Sponsor
Sun Yat-sen University
Collaborators
Nanfang Hospital, Southern Medical University, Guangdong Provincial People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Zhujiang Hospital, Guangzhou First People's Hospital, The Third Affiliated Hospital of Guangzhou Medical University, The Third Affiliated Hospital of Southern Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03194945
Brief Title
Effects of Sequential Treatment Based on Lina/MET After Short-term Intensive Insulin in Newly Diagnosed Type 2 Diabetes
Official Title
Effects of Linagliptin and Metformin Monotherapy or Combined Sequential Treatment After Early Short-term Intensive Insulin Treatment on Long-term Blood Glucose Control and Function of β Cells in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Nanfang Hospital, Southern Medical University, Guangdong Provincial People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Zhujiang Hospital, Guangzhou First People's Hospital, The Third Affiliated Hospital of Guangzhou Medical University, The Third Affiliated Hospital of Southern Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Short-term intensive insulin therapy(SIIT) is able to reverse β cell dysfunction and induce glycemic remission in patients with newly diagnosed type 2 diabetes. However, proportion of patients with response gradually decreases over time. There is no consensus on which treatment should be given in order to maintain the benefit in glycemic control and β cell recovery. In this multi-center, randomized, controlled study, effects of various sequential treatments ( metformin, linagliptin and combined with both drugs) on long-term blood glucose control as well as preservation of β cell function after SIIT were investigated. In total, 448 patients with newly diagnosed type 2 diabetes who meet the inclusive criteria will be enrolled in eight centers in China. After baseline assessments, all patients will be treated with insulin pump to achieve and maintain euglycemia for 2 weeks. After completion of intensive treatment, insulin pump will be stopped. Different treatments will be applied to patients for 48 weeks according to randomization: Group A: Linagliptin 5 mg Qd + Metformin 0.5 g bid; Group B: Linagliptin 5 mg Qd; Group C: Metformin 0.5 g bid; Group D: No oral drugs. Primary endpoint is proportion of patients achieving glycosylated hemoglobin A1C <7% at the end of the study. Secondary endpoints include proportion of patients achieving glycosylated hemoglobin A1C <6.5% at the end of study; differences in β-cell function , insulin sensitivity, GLP-1 and glucagon secretion among treatment groups, and differences in adverse events among treatment groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 diabetes mellitus, Continuous subcutaneous insulin infusion, Metformin, Linagliptin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
448 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Linagliptin plus metformin
Arm Type
Active Comparator
Arm Description
CSII followed by Linagliptin 5 mg Qd + Metformin 0.5 g bid for 48 weeks
Arm Title
Linagliptin
Arm Type
Active Comparator
Arm Description
CSII followed by Linagliptin 5mg Qd for 48 weeks
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
CSII followed by Metformin 0.5 bid for 48 weeks
Arm Title
Lifestyle alone
Arm Type
Active Comparator
Arm Description
No OHA is given after CSII
Intervention Type
Drug
Intervention Name(s)
CSII followed by Lina+MET
Other Intervention Name(s)
CSII+Lina+Met
Intervention Description
short-term intensive CSII followed by Linagliptin 5mg qd and Metformin 0.5g bid for 48 weeks
Intervention Type
Drug
Intervention Name(s)
CSII followed by Lina
Other Intervention Name(s)
CSII+Lina
Intervention Description
short-term intensive CSII followed by Linagliptin 5mg qd for 48 weeks
Intervention Type
Drug
Intervention Name(s)
CSII followed by MET
Other Intervention Name(s)
CSII+Met
Intervention Description
short-term intensive CSII followed by Metformin 0.5g bid for 48 weeks
Intervention Type
Drug
Intervention Name(s)
CSII alone
Other Intervention Name(s)
CSII
Intervention Description
No OHA is given after short-term intensive CSII
Primary Outcome Measure Information:
Title
proportion of subjects with optimal glycemic control
Description
proportion of patients achieving glycosylated hemoglobin A1C <7% at the end of sequential treatment in each treatment group.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
proportion of subjects with excellent glycemic control
Description
proportion of patients achieving glycosylated hemoglobin A1C <6.5% at the end of sequential treatment in each treatment group.
Time Frame
48 weeks
Title
Change of β cell function
Description
Differences in β-cell indicators among treatment arms at the end of study.
Time Frame
48 weeks
Title
Change of insulin sensitivity
Description
Differences in insulin sensitivity indicators among treatment arms at the end of study.
Time Frame
48 weeks
Title
Incidence of adverse events
Description
Differences in incidence of adverse events among treatment arms at the end of study.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with type 2 diabetes who have never received any hypoglycemic treatment, or patients with type 2 diabetes <1 year from diagnosis who have used no more than 1 type of hypoglycemic drug for no more than 1 week and discontinued for more than 4 weeks before enrollment; Fasting plasma glucose (FPG) between 7.0 mmol/l (126 mg/dl) and 16.7 mmol/l (300 mg/dl); glycosylated hemoglobin A1C>8.5%; Aged between 25 and 65 years, body mass index (BMI) 22-35 kg/m2. Exclusion Criteria: Type 1 diabetes or special type of diabetes; Acute complications of diabetes (including DKA, HHS and lactic acidosis) Serious microvascular complications: proliferative stage of retinopathy; urine AER >300 mg/g or urine protein positive, quantification >0.5 g/d; uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy; Severe macrovascular complications: acute cerebrovascular accident, acute coronary syndrome, vascular intervention for peripheral arterial disease or amputation requiring hospitalization within 12 months prior to enrollment; Persistently increased blood pressure >180/110 mmHg; Blood creatinine clearance less than 50 ml/min, alanine aminotransferase ≥2.5×upper limit of normal, total bilirubin ≥1.5×upper limit of normal; Hemoglobin <100 g/L or need regular blood transfusion; Use of drugs that may influence blood glucose within 12 weeks; Systemic infection or serious concomitant disease; patients with malignancy or chronic diarrhea; Uncontrolled endocrine gland dysfunction; Patients with mental or communication disorders; Chronic cardiac insufficiency, heart function class III and above; Pregnant women, lactating women and women of child bearing age who are not willing to take contraception during the study; Subjects who don't cooperate, cannot be followed up or have difficulty in completing the study considered by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liehua Liu, PHD
Phone
+8613751748843
Email
turkey310@163.com
Facility Information:
Facility Name
endocrinology department of the first affiliated hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanbing Li, MD,PhD
Phone
8602087334331
Email
easd04lyb@126.com
First Name & Middle Initial & Last Name & Degree
Yanbing Li, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effects of Sequential Treatment Based on Lina/MET After Short-term Intensive Insulin in Newly Diagnosed Type 2 Diabetes

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