SAM - Skip a Meal - Insulin Glargine, Diabetes Mellitus Type 1

NCT00313937 | Completed Phase 4

• 1 other identifier: HOE901_4028
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective: To compare metabolic control as measured by Blood Glucose (BG) upon arising from bed (7:00 am - 12:00 pm) in type 1 Diabetes mellitus patients who skip the morning meal during treatment with MDI basal/bolus insulin: Difference of change of blood glucose between 7:00 am and 11:00 am between patients on Insulin glargine and NPH insulin. Secondary objective: To perform an evaluation between the two patient groups for BG (10:00 pm and 12:00 pm) as well as for serum insulin, free fatty acid levels and β-hydroxybutyrate (7:00 am - 12:00 pm).

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Difference of change of blood glucose between patients on Insulin glargine and NPH insulin.

  between 7:00 am and 11:00 am

Interventions

Insulin glargine DRUG

Eligibility Criteria

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

You may qualify if:

• Patients with type 1 Diabetes mellitus who have been treated with MDI (Multiple Daily Injection) basal/bolus insulin, regular insulin/short acting insulin analogue + NPH insulin on a stable dose (no change more than 10 %) for at least 4 weeks prior to study entry, who have an HBA1c smaller/equal 9 % (measured at visit 1) and a BMI smaller/equal 35 kg/m2. In addition, patients must have a FBG value at day 1 before skipping meal (6:00 am - 07:00 am) between 90 - 120 mg/dl (5.0 - 6.5 mmol/l).

You may not qualify if:

• Breast-feeding
• History of hypersensitivity to the study medication or to drugs with similar chemical structures
• Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
• Treatment with any investigational drug in the last 30 days before study entry
• Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
• History of drug or alcohol abuse
• No subjects who have previously been treated with Insulin glargine will be enrolled in this study.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Berlin, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

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

• Wolfgang Landgraf, Dr.

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 11, 2006
• First Posted: April 12, 2006
• Study Start: November 1, 2001
• Primary Completion: June 1, 2004
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

DE (1)