Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Evaluation of Efficacy and Safety of HMR1964 (Insulin Glulisine) in Subjects With Type 1 Diabetes Mellitus; Insulin Lispro Controlled, Open, Randomized, Parallel Group, Non-inferiority Study, for 28 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290979
• Other study ID #: EFC6167
• Status: Completed
• Phase: Phase 3
• First received: February 10, 2006
• Last updated: August 25, 2009
• Start date: December 2004

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

• To evaluate non-inferiority in the efficacy of HMR1964 as compared with Insulin lispro in terms of the change in HbA1C from baseline to endpoint.

• To compare the safety of HMR1964 with insulin lispro.

Description:

• To compare HMR1964 with insulin lispro in terms of the change in HbA1C from baseline to week 12 and week 28; consecutive change in HbA1C by every 4 weeks, blood glucose parameters, symptomatic hypoglycemia and insulin doses (rapid-acting, basal and total).

• To collect 6-month safety data of HMR1964.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women with type 1 diabetes mellitus, an HbA1C range of >=6.0 - =<11.0%, and on a basal-bolus insulin regimen. They must have had at least 1 year of continuous insulin treatment at the date of informed consent.

Exclusion Criteria:

• Subjects who received an oral hypoglycemic agent other than insulin within 4 weeks prior to informed consent

• Subjects who received oral or intravenous corticosteroid within 4 weeks prior to informed consent

• Subjects who were treated with another investigational product within 12 weeks prior to informed consent

• Subjects with likelihood of requiring concomitant treatment during the study period with drugs not permitted by this study protocol

• Subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine, active cancer, other serious complication or systemic disease making implementation of the protocol or interpretation of the study results difficult

• Subjects who have undergone pancreatectomy or pancreas/islet cell transplant

• Night shift workers

• Subjects unlikely to comply with the study protocol, e.g., inability to periodic return for follow-up visits, and unlikelihood of completing the study

• Subjects who have previously been treated with HMR1964

• Subjects who are pregnant, breast feeding or wish to become pregnant during the study period

• Female subjects who are possibly pregnant [female subjects of reproductive potential who have serum human chorionic gonadotropin (hCG) level > 0.7 mIU/mL as determined by central laboratory, SRL Medisearch Inc., during screening phase]

• Subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 24 weeks prior to informed consent, or who are expected to have these surgical treatments during the study period

• Subjects with history of alcohol abuse

• Subjects with hypersensitivity to insulin preparations

• Subjects with impaired hepatic function (SGOT or SGPT ³=<80 IU/L determined by central laboratory, SRL Medisearch Inc., during screening phase) or impaired renal function (serum creatinine =<2.0 mg/dL determined by central laboratory, SRL Medisearch Inc., during screening phase)

• Subjects who are judged by the investigator or subinvestigator as inappropriate as the subjects of this study for any other reason

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 1

Intervention

Drug:
• insulin glulisine

Locations

Country	Name	City	State
Japan	Sanofi-Aventis	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Kawamori R, Kadowaki T, Ishii H, Iwasaki M, Iwamoto Y. Efficacy and safety of insulin glulisine in Japanese patients with type 1 diabetes mellitus. Diabetes Obes Metab. 2009 Sep;11(9):891-9. doi: 10.1111/j.1463-1326.2009.01086.x. Epub 2009 Jul 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferiority in the efficacy and safety of HMR1964 as compared with Insulin lispro
Secondary	6-month safety data