Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure

NCT01461577 | Completed Phase 4

• 2 other identifiers: LANTU_L_05477U1111-1118-8753
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:

• To assess the efficacy of insulin glargine as measured by changes of HbA1c levels from baseline in type 2 diabetes mellitus (T2DM) patients following GLP-1 failure. Secondary Objective:
• To determine the change in glycemic control, safety, and treatment satisfaction in insulin glargine use in patients following GLP-1 failure.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline

  24 weeks

Secondary Outcomes (10)

• Responder rate (HbA1c levels <7%) without severe hypoglycemia

  24 weeks

• Responder rate (HbA1c levels <6.5% and <7%)

  24 weeks

• Changes of fasting plasma glucose (FPG) levels from baseline

  24 weeks

• Changes of beta cell marker: C-peptide from baseline

  24 weeks

• Changes of Lipid profile: Lipid profile from baseline

  24 weeks

Study Arms (1)

insulin glargine

EXPERIMENTAL

Insulin glargine will be administered once a day, in the morning, at initial dose of 4 units/day. Titration of insulin dose will be performed referred with the median fasting plasma glucose value for the last 3 consecutive days according to the titration algorithm

Drug: INSULIN GLARGINE HOE 901

Interventions

INSULIN GLARGINE HOE 901 DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

insulin glargine

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of aged ≥30 and ≤75 years with type 2 diabetes mellitus (T2DM)
• Hemoglobin A1c (glycosylated hemoglobin; HbA1c) levels measured at screening ≥7.5%
• Continuous treatment with stable doses of GLP-1 analogue for \>3 months prior to enrollment (for patients also using oral anti-hyperglycemic drugs \[OADs\], continuous treatment with stable doses of OADs for \>3 months prior to enrollment)

You may not qualify if:

• Inpatient with T2DM
• Diabetes other than T2DM (e.g. secondary to pancreatic disorders, drug or chemical agent intake)
• Fasting plasma glucose (FPG) levels \<130mg/dL
• Body mass index (BMI) \>28 kg/m2
• Patients using thiazolidinediones in the last 3 months prior to enrollment
• Use of any treatment for weight loss in the last 3 months prior to enrollment
• Treatment with systemic corticosteroids within the 3 months prior to enrollment
• Patients using non-selective ß-blockers
• Likelihood of requiring treatment during the study period with drugs not permitted by the clinical trial protocol
• Most recent ophthalmologic examination \>6 months prior to enrollment
• Diabetic retinopathy with surgical treatment (last photocoagulation or vitrectomy) in the 3 months before enrollment or which may require surgical treatment
• Proliferative diabetic retinopathy or any other unstable rapidly progressive retinopathy
• Impaired renal function defined as, but not limited to, serum creatinine ≥1.3 mg/dL \[males\] or ≥1.2 mg/dL \[females\] or presence of macroproteinuria (\>1 g/day)
• Active liver disease including hepatic cirrhosis, hepatic failure, and hepatitis or alanine transaminase (ALT) or aspartate aminotransferase (AST) \>2 times upper limit or total bilirubin \>1.5 times upper limit of normal (except in case of Gilbert's syndrome) at enrollment
• Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Administrative office

Tokyo, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

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

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: October 26, 2011
• First Posted: October 28, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 30, 2013

Record last verified: 2013-01

Locations

JP (1)