Diabetes Mellitus, Type 2
Conditions
Brief summary
Primary Objective: To investigate the efficacy(HbA1c) at 6 months after adding basal insulin therapy (insulin glargine) to dipeptidyl peptidase-IV (DPP-IV) and metformin plus or minus sulphonylurea Secondary Objectives: 1. To assess the efficacy by adding insulin glargine 2. To assess insulin dose 3. Safety
Detailed description
28 weeks (Screening: About 2 weeks/Treatment: 24 weeks (6 months)/Follow-up: 2 weeks)
Interventions
DRUGINSULIN GLARGINE
Pharmaceutical form: solution Route of administration: subcutaneous
DRUGMetformin
Pharmaceutical form: tablet Route of administration: oral
DRUGDPP-4 inhibitor
Pharmaceutical form: tablet Route of administration: oral
DRUGSulphonylurea
Pharmaceutical form: tablet Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Patients with type 2 Diabetes mellitus ≥ 20 aged * Patients who are treated with DPP- 4 for at least 3 months before informed consent with metformin plus or minus sulphonylurea inadequately controlled with HbA1c ≥ 7.5% * Be able and voluntarily agree to participate in this study by signing a written informed consent
Exclusion criteria
* Diabetes patients other than Type 2 (eg. Type 1 Diabetes mellitus, pancreatic disease, secondary diabetes) * HbA1c \> 11% at screening * History of continuous basal insulin treatment within 1 year before screening * History of diabetic acidosis (including keto-acidosis) within 1 year before screening * History of myocardial infarct, stroke or heart failure related admission within 3 months before screening * History of drug or alcoholic abuse within 6 months before screening * Weight change ≥ 5 kg within 3 months before screening * History of hypoglycemic unawareness * Systolic blood pressure \>180 mmHg or diastolic blood pressure \> 110 mmHg regardless of taking anti-hypertensive, or uncontrolled hypertension * Active malignant cancer, major systemic disease, clinically significant diabetic retinopathy, macular edema necessitating laser treatment, abnormal clinical finding from physical examination, lab analysis, electrocardiogram or vital sign, which can be regarded as to prevent safe completion of clinical study or to make efficacy assessment difficult by investigator or co-investigator at screening * Pregnant or lactating women * Women of child bearing potential (Pre-menopause or not surgically infertile within 3 months before screening) who match two conditions below: * Negative serum pregnancy test at screening * Using medically proven effective contraceptive method * Hypersensitivity to investigational drugs * Lab finding at screening: * Abnormal liver function: Alanine transaminase or Alkaline phosphatase \> 3 times of upper limit of normal range * Renal insufficiency: Men with serum Cr ≥ 1.5 mg/dL (≥ 133µmol/L), women with serum Cr ≥ 1.4 mg/dL (≥ 124 µmol/L) * Use of anti-obese drug within 3 months before screening * Has been using drugs that can influence glucose metabolism (systemic corticosteroid, thyroid hormone) within 3 months before screening or has possibility of using these drug during the investigational period * Has participated in clinical studies of any investigational drugs within 3 months before screening * Considered not physically or psychologically appropriate to participate in clinical study by investigator * Not willing to comply with scheduled visit, self-inject insulin, or self-monitor blood glucose level 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 |
|---|---|
| Response rate (percentage of patients who meet the target HbA1c ≤7%) at week 24 (6 months) after adding insulin therapy | week 24 (6 months) |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c | week 12 (3 months), week 24 (6 months) |
| Percentage of patients with HbA1c ≤6.5% | week 12 (3 months), week 24 (6 months) |
| Change from baseline in Fasting Plasma glucose (FPG), 2hr-Postprandial Plasma Glucose | week 12 (3 months), week 24 (6 months) |
| Total daily insulin dose | week 24 (6 months) |
| Percentage of patients with HbA1c ≤7% | week 12 (3 months) |
| 7-point Self Monitoring of Blood Glucose | During 2 days within 7 days before baseline, week 12, week 24 |
| Weight change from baseline | week 24 (6 months) |
| Number of Patients with Hypoglycemic Events | up to 6 months |
| Number of Patients with Adverse Events | up to 6 months |
| Fasting blood glucose (FBG) values | During 3 consecutive days before baseline, week 12, Week 24 |
Countries
South Korea
Outcome results
None listed