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

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)

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: INSULIN GLARGINE; Drug: Metformin; Drug: DPP-4 inhibitor; Drug: Sulphonylurea

Detailed Description

28 weeks (Screening: About 2 weeks/Treatment: 24 weeks (6 months)/Follow-up: 2 weeks)

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insulin glargine and Oral anti diabetic treatment(s); Insulin glargine: LantusAdd basal insulin: starting with 0.2 U/kg/day or 10 U/dayAdjust 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with HbA1c ≤7%	week 12 (3 months)
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)
Fasting blood glucose (FBG) values	During 3 consecutive days before baseline, week 12, Week 24
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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: January 3, 2014
• First Submitted That Met QC Criteria: January 3, 2014
• First Posted (Estimate): January 6, 2014

Study Record Updates

• Last Update Posted (Estimate): August 27, 2015
• Last Update Submitted That Met QC Criteria: August 26, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Metformin; Insulin Glargine; Dipeptidyl-Peptidase IV Inhibitors
• Other Study ID Numbers: LANTUL06638; U1111-1149-1632 (Other Identifier: UTN)