Treatment of Early Insulinization With Glargine in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea or Metformin Monotherapy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 387
- Locations
- 1
- Primary Endpoint
- A1c values
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Administration of Insulin Glargine and Sulfonylurea or Metformin
Intervention: Insulin Glargine (Drug)
1
Administration of Insulin Glargine and Sulfonylurea or Metformin
Intervention: Metformin (Drug)
2
Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
Intervention: Glyburide (Drug)
2
Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
Intervention: Glyclazide (Drug)
2
Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
Intervention: Glimiperide (Drug)
2
Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
Intervention: Glipizide (Drug)
2
Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
Intervention: Metformin (Drug)
Outcomes
Primary Outcomes
A1c values
Time Frame: At baseline and 24 weeks
Secondary Outcomes
- Adverse events including hypoglycemia(From the beginning to the end of the study)