Insulin Glargine in Type 2 Diabetic Patients

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

Completed

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

Throughout study period