Diabetes Mellitus, Type 2
Conditions
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
Interventions
DRUGInsulin Glargine
Throughout study period
DRUGGlyburide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
DRUGGlyclazide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
DRUGGlimiperide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
DRUGGlipizide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
DRUGMetformin
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A1c values | At baseline and 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events including hypoglycemia | From the beginning to the end of the study |
Countries
China
Outcome results
None listed