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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: INSULIN GLARGINE HOE 901 (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

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.

Clinical Details

Official title: A Multicenter, Open-label, Single-arm, 24 Week Phase IV Study Evaluating the Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline

Secondary outcome:

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

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

Changes of fasting plasma glucose (FPG) levels from baseline

Changes of beta cell marker: C-peptide from baseline

Changes of Lipid profile: Lipid profile from baseline

Weight change from baseline

Total insulin dose (per kg body weight)

Evaluation of patient's treatment satisfaction

Number of patients with hypoglycemia

Number of patients with treatment-emergent adverse events

Detailed description: 1-2 weeks screening period, 24 weeks treatment period, 1 week follow-up period

Eligibility

Minimum age: 30 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- 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) Exclusion criteria:

- 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

- Any medical condition that may have an influence on HbA1c rate

- Currently undergoing therapy for malignancy which may affect the study evaluation

- Use of any investigational product and/or device within the 2 months prior to

enrollment

- History of ketoacidosis or hyperosmolar hyperglycemic state during the previous 12

months prior to enrollment

- History of stroke, myocardial infarction, angina pectoris, coronary artery bypass

graft or percutaneous transluminal coronary angioplasty within the previous 12 months prior to enrollment

- History of congestive heart failure

- History of hypoglycemia unawareness or unexplained hypoglycemia during the previous

12 months prior to enrollment

- Hemoglobinopathy or hemolytic anemia, transfusion of blood or plasma products within

3 months prior to enrollment

- Known hypersensitivity / intolerance to insulin glargine or any of its excipients

- History of pancreatitis

- Pregnant or breast-feeding women (women of childbearing potential must have a

negative pregnancy test at study entry and a medically approved contraception method)

- Shift workers or those who regularly work a night-time shift

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations and Contacts

Administrative office, Tokyo, Japan
Additional Information

Starting date: November 2011
Last updated: January 29, 2013

Page last updated: August 23, 2015

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