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Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Insulin Glargine
Sitagliptin
Metformin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

35 Years - 71 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Patients who completed the core study LANTU_C_02761 (NCT00751114) i.e. went through the visit 14 investigation,
  • HbA1c >= 7 %,
  • Dose of metformin compliant with the inclusion criteria of the core study (i.e. at least 1 g/day), and maintained stable for the duration of the core study
  • Ability and willingness to perform plasma blood glucose monitoring using the sponsor-provided plasma glucose meter and to complete the patient dairy,
  • Signed informed consent obtained prior any study procedure,
  • Willingness and ability to comply with the study protocol.

Exclusion Criteria:

  • Treatment with oral antidiabetic drugs other than metformin and sitagliptin in the core study,
  • Treatment with insulin other than Insulin Glargine in the core study (except in case of an emergency, for a period of time less than 7 days),
  • Treatment with a non-permitted drug during the core study,
  • Pregnant or lactating women,
  • In-patient care,
  • Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry in the core study),
  • Impaired renal function: serum creatinine >= 1.5 mg/dL (>= 133µmol/L) or >= 1.4 mg/dL (>=124 µmol/L) in men and women, respectively,
  • History of sensitivity to the study drugs or to drugs with a similar chemical structure,
  • Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 3 x upper limit of normal range,
  • Alcohol or drug abuse within the last year,
  • Night shift worker,
  • Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient's safety or limit the patient successful participation in the study,
  • Treatment with weight loss medications (e.g. sibutramine, orlistat, rimonabant),
  • History of pancreatitis.

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination insulin glargine and sitagliptin

Arm Description

Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 < Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L). Sitagliptin: stable dose of 100 mg once a day administered with or without food.

Outcomes

Primary Outcome Measures

HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period)

Secondary Outcome Measures

HbA1c: Change From Baseline to Study Endpoint
Change = study endpoint - baseline
Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint
SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed). Change = study endpoint - baseline.
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime. Change = study endpoint - baseline.
Insulin Dose
Daily dose at the face-to-face visits
Number of Patients With at Least One Episode of Symptomatic Hypoglycemia
Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L]
Change in Body Weight From Baseline to Study Endpoint
Change = study endpoint - baseline

Full Information

First Posted
February 25, 2009
Last Updated
September 3, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00851903
Brief Title
Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial
Official Title
Combination Therapy of Insulin Glargine and Sitagliptin in Patients With Type 2 Diabetes Not Adequately Controlled by a Previous Treatment With Metformin and Either Insulin Glargine or Sitagliptin
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
This study was the extension of the LANTU_C_02761 study named EASIE and identified as NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled). All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had the possibility to enter this extension study if they met the other inclusion criteria and did not present with any exclusion criteria. The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension study which consisted of a 12-week treatment period. The objectives of this extension study were: To assess the glycemic control (HbA1c <7%) of a 3-month combination therapy with metformin, insulin glargine and sitagliptin in patients not adequately controlled by a previous treatment with metformin plus either insulin glargine or sitagliptin. To assess the effect of insulin glargine in combination with sitagliptin on HbA1c level, fasting plasma glucose, 7-point glucose profile, hypoglycemia occurrence, body weight and overall safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination insulin glargine and sitagliptin
Arm Type
Experimental
Arm Description
Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 < Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L). Sitagliptin: stable dose of 100 mg once a day administered with or without food.
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Other Intervention Name(s)
Lantus®
Intervention Description
Subcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL).
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Other Intervention Name(s)
Januvia®
Intervention Description
Oral administration. 100mg film-coated tablets.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Patients continued with metformin as usual oral anti-diabetic treatment.
Primary Outcome Measure Information:
Title
HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period)
Time Frame
study endpoint: week 12 or earlier in case of premature discontinuation
Secondary Outcome Measure Information:
Title
HbA1c: Change From Baseline to Study Endpoint
Description
Change = study endpoint - baseline
Time Frame
baseline, study endpoint: week 12 or earlier in case of premature discontinuation
Title
Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint
Description
SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed). Change = study endpoint - baseline.
Time Frame
baseline, study endpoint: week 12 or week 8 if value not available at week 12
Title
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
Description
7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime. Change = study endpoint - baseline.
Time Frame
baseline, study endpoint: week 12 or week 8 if value not available at week 12
Title
Insulin Dose
Description
Daily dose at the face-to-face visits
Time Frame
baseline, week 4, week 8, week 12
Title
Number of Patients With at Least One Episode of Symptomatic Hypoglycemia
Description
Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L]
Time Frame
During the treatment period (12 weeks) plus 7 days after last dose
Title
Change in Body Weight From Baseline to Study Endpoint
Description
Change = study endpoint - baseline
Time Frame
baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients who completed the core study LANTU_C_02761 (NCT00751114) i.e. went through the visit 14 investigation, HbA1c >= 7 %, Dose of metformin compliant with the inclusion criteria of the core study (i.e. at least 1 g/day), and maintained stable for the duration of the core study Ability and willingness to perform plasma blood glucose monitoring using the sponsor-provided plasma glucose meter and to complete the patient dairy, Signed informed consent obtained prior any study procedure, Willingness and ability to comply with the study protocol. Exclusion Criteria: Treatment with oral antidiabetic drugs other than metformin and sitagliptin in the core study, Treatment with insulin other than Insulin Glargine in the core study (except in case of an emergency, for a period of time less than 7 days), Treatment with a non-permitted drug during the core study, Pregnant or lactating women, In-patient care, Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry in the core study), Impaired renal function: serum creatinine >= 1.5 mg/dL (>= 133µmol/L) or >= 1.4 mg/dL (>=124 µmol/L) in men and women, respectively, History of sensitivity to the study drugs or to drugs with a similar chemical structure, Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 3 x upper limit of normal range, Alcohol or drug abuse within the last year, Night shift worker, Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient's safety or limit the patient successful participation in the study, Treatment with weight loss medications (e.g. sibutramine, orlistat, rimonabant), History of pancreatitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Vienna
Country
Austria
Facility Name
Sanofi-Aventis Administrative Office
City
Sao Paulo
Country
Brazil
Facility Name
Sanofi-Aventis Administrative Office
City
Bogota
Country
Colombia
Facility Name
Sanofi-Aventis Administrative Office
City
Cairo
Country
Egypt
Facility Name
Sanofi-Aventis Administrative Office
City
Kallithea
Country
Greece
Facility Name
Sanofi-Aventis Administrative Office
City
Hong Kong
Country
Hong Kong
Facility Name
Sanofi-Aventis Administrative Office
City
Mumbai
Country
India
Facility Name
Sanofi-Aventis Administrative Office
City
Natanya
Country
Israel
Facility Name
Sanofi-Aventis Administrative Office
City
Seoul
Country
Korea, Republic of
Facility Name
Sanofi-Aventis Administrative Office
City
Beirut
Country
Lebanon
Facility Name
Sanofi-Aventis Administrative Office
City
Col. Coyoacan
Country
Mexico
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Porto Salvo
Country
Portugal
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Guildford Surrey
Country
United Kingdom

12. IPD Sharing Statement

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Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial

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