OPAL - Insulin Glulisine, Diabetes Mellitus

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Efficacy and Safety of Insulin Glulisine Given as a Single Injection at Breakfast + Insulin Glargine+OAD (Oral Antidiabetic Drug) vs Insulin Glulisine Given as a Single Injection at Main Meal+Insulin Glargine+OAD in Type 2 Diabetic Patients for Which Glycemic Control is Suboptimal Using Insulin Glargine+ OAD Alone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272012
• Other study ID #: HMR1964A_3507
• Status: Completed
• Phase: Phase 3
• First received: January 2, 2006
• Last updated: December 4, 2009
• Start date: July 2004

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Primary objective:

The primary study objective is to compare efficacy of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of change in HbA1c, from baseline to endpoint for the individual patient. The aim of the study is to demonstrate two-sided equivalence between the two therapy regimens receiving two different injection timing of Insulin glulisine.

Secondary objective:

Secondary study objectives are to compare efficacy and safety of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of:

• Change of fasting-, pre-/2h-postprandial-, mean daily and nocturnal blood glucose (baseline to endpoint)

• Change of fasting plasma glucose (baseline to endpoint)

• Response rate: Responders will be those patients with HbA1c smaller than 7.0% at study endpoint

• Insulin dose (rapid-acting, basal and total daily doses)

• Weight, body-mass index

• Hypoglycemic events

• Adverse events

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Type 2 Diabetes mellitus, previously treated with combination therapy of insulin glargine + OAD (maximal tolerated dose / approved in combination with insulin according to local SPCs (Summary of Product Characteristics), not including use of a-glucosidase inhibitors) for at least 3 months

• Pre-screening HbA1c value greater/equal 7% - smaller/equal 9%

• FBG (Fasting Blood Glucose) smaller/equal 120 mg/dl (6.6 mmol/l)

• Women are either not of childbearing potential (surgically sterile, or postmenopausal for more than 2 years) or are not pregnant and agree to use a reliable contraceptive measure for the duration of the study. Reliable contraceptive measures include the following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide.

• Ability and willingness to perform blood glucose monitoring using the sponsor-provided blood glucose meter and subject diary at home

Exclusion criteria:

• More than two FBG greater 120 mg/dl (6.6 mmol/l) as measured on 5 consecutive days before visit II

• Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation)

• Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult

• Known impaired hepatic and renal function

• History of drug or alcohol abuse

• History of hypersensitivity to insulin or insulin analogues or any of the excipients in the Insulin glulisine formulation

• Treatment with any investigational drug in the last month before visit I

• Pregnant or breast-feeding women, or women planning to become pregnant during the study

• Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol

• Night shift workers if they are unable to comply with the treatment regimen

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin glulisine

Locations

Country	Name	City	State
Germany	Sanofi-Aventis	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c.		from baseline to study endpoint.	No
Secondary	Change of pre-, 2 h postprandial and nocturnal blood glucose values		8-point profile	No
Secondary	Fasting blood glucose		8-point blood glucose profile values	No
Secondary	Responder rate HbA1c smaller 7 %		at study endpoint	No
Secondary	Insulin dose		rapid-acting, basal and total daily doses	No
Secondary	Weight, BMI		study follow-up	No
Secondary	Hypoglycemic events		study follow-up	Yes
Secondary	Adverse events.		study follow-up	Yes