Insulin Glargine in Type 2 Diabetic Patients

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin Glargine; Drug: Glyburide; Drug: Metformin; Drug: Glyclazide; Drug: Glimiperide; Drug: Glipizide

• Registration Number: NCT00347100
• Lead Sponsor: Sanofi

Brief Summary

Primary:

* To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline to endpoint A1c \< 7%)

Secondary:

* To investigate the safety of insulin glargine (in terms of hypoglycaemia, including symptomatic, non-symptomatic and nocturnal hypoglycaemia)

* To investigate whether beta cell function is preserved if this therapy is initiated before 2nd OAD (oral anti-diabetic drug) failure

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study First Posted: 2006-07-04
• Primary Completion: 2008-05
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 387

Inclusion Criteria

• Type 2 diabetes patients with first OAD (Sulfonylurea [SU] or Metformin) failure
• Patients who are insulin naive (unless it was used for gestational diabetes or if insulin therapy was less than 1 week)
• Serum creatinine ≤ 1.5mg/dL
• BMI: 21-41 kg/m²
• 7.5%< A1c <11%
• Fasting plasma glucose > 7.5mmol/L
• On diet and exercise therapy and stable OAD treatment (SU or metformin > ½ maximal dose)for more than 1 month prior to enrolment
• Women not of childbearing potential (sterilization procedure done or menopausal > 2 years), or if of childbearing potential, agree to take reliable contraceptive measures during the study
• Able and willing to monitor blood glucose
• Able and willing to perform 7 point blood glucose self monitoring at baseline, 12 week and 24 week
• Understand that there is a 50% chance of being randomized to the insulin treatment arm and is willing to self inject insulin

Exclusion Criteria

• Type 1 diabetes
• Acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma
• Pregnancy, breast-feeding
• People who work night shifts
• Hypersensitivity to investigational drugs or its additives, or intolerability to metformin
• Need for use of medications prohibited by the protocol during the study for treatment purpose
• Significant diseases in cardiovascular, liver, nerve, endocrine or other systems, unable to complete the study or difficult to be used in study analysis
• Drugs or alcohol abuse

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Insulin Glargine	Administration of Insulin Glargine and Sulfonylurea or Metformin
1	Metformin	Administration of Insulin Glargine and Sulfonylurea or Metformin
2	Glimiperide	Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
2	Glyburide	Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
2	Glyclazide	Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
2	Glipizide	Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
2	Metformin	Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin

Primary Outcome Measures

Name	Time	Method
A1c values	At baseline and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events including hypoglycemia	From the beginning to the end of the study

Trial Locations

Locations (1)

Sanofi-Aventis; 🇨🇳 Beijing, China