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

NCT02027753 | Completed Phase 4

• 2 other identifiers: LANTUL06638U1111-1149-1632
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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. 1.To assess the efficacy by adding insulin glargine
2. 2.To assess insulin dose
3. 3.Safety

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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)

Study Arms (1)

Insulin glargine and Oral anti diabetic treatment(s)

EXPERIMENTAL

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.

Drug: INSULIN GLARGINE; Drug: Metformin; Drug: DPP-4 inhibitor; Drug: Sulphonylurea

Interventions

INSULIN GLARGINE DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Insulin glargine and Oral anti diabetic treatment(s)

Metformin DRUG

Pharmaceutical form: tablet Route of administration: oral

Insulin glargine and Oral anti diabetic treatment(s)

DPP-4 inhibitor DRUG

Pharmaceutical form: tablet Route of administration: oral

Insulin glargine and Oral anti diabetic treatment(s)

Sulphonylurea DRUG

Pharmaceutical form: tablet Route of administration: oral

Insulin glargine and Oral anti diabetic treatment(s)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Metformin; Dipeptidyl-Peptidase IV Inhibitors; Sulfonylurea Compounds

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Urea; Amides; Sulfones; Sulfur Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 6, 2014
• Study Start: December 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 27, 2015

Record last verified: 2015-08

Locations

KR (1)