Efficacy and Safety of Insulin Glargine in Patients With Type 2 Diabetes With Inadequate Control on DPP-4 Inhibitor Therapy
Overview[ - collapse ][ - ]
Purpose | 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 |
---|---|
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: INSULIN GLARGINE Drug: Metformin Drug: DPP-4 inhibitor Drug: Sulphonylurea |
Phase | Phase 4 |
Sponsor | Sanofi |
Responsible Party | Sanofi |
ClinicalTrials.gov Identifier | NCT02027753 |
First Received | January 3, 2014 |
Last Updated | January 6, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | January 3, 2014 |
---|---|
Last Updated Date | January 6, 2014 |
Start Date | December 2013 |
Estimated Primary Completion Date | May 2015 |
Current Primary Outcome Measures | Response rate (percentage of patients who meet the target HbA1c ≤7%) at week 24 (6 months) after adding insulin therapy [Time Frame: week 24 (6 months)] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety of Insulin Glargine in Patients With Type 2 Diabetes With Inadequate Control on DPP-4 Inhibitor Therapy |
---|---|
Official Title | Efficacy and Safety of TrEating Type 2 Diabetic Patients With Inadequate Response to Metformin and DPP-4 Inhibitors by Adding Basal Insulin Therapy (Insulin Glargine) |
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) |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: INSULIN GLARGINE Pharmaceutical form: solution Route of administration: subcutaneous Drug: Metformin Pharmaceutical form: tablet Route of administration: oral Drug: DPP-4 inhibitor Pharmaceutical form: tablet Route of administration: oral Drug: Sulphonylurea Pharmaceutical form: tablet Route of administration: oral |
Study Arm (s) | Experimental: Insulin glargine and Oral anti diabetic treatment(s) Insulin glargine: Lantus Add basal insulin: starting with 0.2 U/kg/day or 10 U/day Adjust insulin glargine dose according to Fasting blood glucose Oral Anti Diabetic treatment(s): DPP-4 inhibitors and Metformin plus or minus Sulphonylurea - Only Sulphonylurea can either be omitted or reduced at the physician's discretion. |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
---|---|
Estimated Enrollment | 108 |
Estimated Completion Date | May 2015 |
Estimated Primary Completion Date | May 2015 |
Eligibility Criteria | 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 > 10% 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. |
Gender | Both |
Ages | 20 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Trial Transparency Team Contact-US@sanofi.com |
Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02027753 |
---|---|
Other Study ID Numbers | LANTUL06638 |
Has Data Monitoring Committee | No |
Information Provided By | Sanofi |
Study Sponsor | Sanofi |
Collaborators | Not Provided |
Investigators | Study Director: Clinical Sciences & Operations Sanofi |
Verification Date | January 2014 |
Locations[ + expand ][ + ]
Sanofi-Aventis Administrative Office | Seoul, Korea, Republic of Recruiting |
---|