Insulin Glargine in Type 2 Diabetic Patients (TARGET)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00347100
First received: June 30, 2006
Last updated: September 14, 2009
Last verified: September 2009
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Insulin Glargine Drug: Glyburide Drug: Glyclazide Drug: Glimiperide Drug: Glipizide Drug: Metformin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Early Insulinization With Glargine in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea or Metformin Monotherapy |
Resource links provided by NLM:
Drug Information available for:
Metformin
Metformin hydrochloride
Glyburide
Insulin human
Glipizide
Insulin glargine
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- A1c values [ Time Frame: At baseline and 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events including hypoglycemia [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: Yes ]
| Enrollment: | 387 |
| Study Start Date: | June 2006 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Administration of Insulin Glargine and Sulfonylurea or Metformin
|
Drug: Insulin Glargine
Throughout study period
Drug: Metformin
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
|
|
Active Comparator: 2
Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
|
Drug: Glyburide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Drug: Glyclazide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Drug: Glimiperide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Drug: Glipizide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Drug: Metformin
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00347100 History of Changes |
| Other Study ID Numbers: | LANTU_L_01051 |
| Study First Received: | June 30, 2006 |
| Last Updated: | September 14, 2009 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glargine Glyburide Gliclazide |
Glipizide Insulin Metformin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013