Efficacy and Safety of Insulin Glargine in Patients With Type 2 Diabetes With Inadequate Control on DPP-4 Inhibitor Therapy

NCT ID: NCT02027753

Last Updated: 2015-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-04-30

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)

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin glargine and Oral anti diabetic treatment(s)

1. 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

2. 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.

Group Type: EXPERIMENTAL

INSULIN GLARGINE

Intervention Type: DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Metformin

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral

DPP-4 inhibitor

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral

Sulphonylurea

Intervention Type: DRUG

Pharmaceutical form: tablet Route of administration: oral

Interventions

INSULIN GLARGINE

Pharmaceutical form: solution Route of administration: subcutaneous

Intervention Type: DRUG

Metformin

Pharmaceutical form: tablet Route of administration: oral

Intervention Type: DRUG

DPP-4 inhibitor

Pharmaceutical form: tablet Route of administration: oral

Intervention Type: DRUG

Sulphonylurea

Pharmaceutical form: tablet Route of administration: oral

Intervention Type: DRUG

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 > 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Seoul, , South Korea

Countries

South Korea

Other Identifiers

U1111-1149-1632

Identifier Type: OTHER

Identifier Source: secondary_id

LANTUL06638

Identifier Type: -

Identifier Source: org_study_id