Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus

NCT00290979 | Completed Phase 3

• 1 other identifier: EFC6167
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Keywords

HMR1964, insulin glulisine, Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Non-inferiority in the efficacy and safety of HMR1964 as compared with Insulin lispro

Secondary Outcomes (1)

• 6-month safety data

Interventions

insulin glulisine DRUG

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Tokyo, Japan

Location

Related 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.

  PMID: 19614947 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

insulin glulisine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Masayoshi KOYAMA

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 10, 2006
• First Posted: February 13, 2006
• Study Start: December 1, 2004
• Last Updated: August 26, 2009

Record last verified: 2009-03

Locations

JP (1)