Status:
COMPLETED
Comparison of Insulin Glargine and NPH Insulin at Night and at Hypoglycemia in Type 2 Diabetes
Lead Sponsor:
University of Giessen
Collaborating Sponsors:
Sanofi
Conditions:
Diabetes
Eligibility:
All Genders
Brief Summary
Long-acting insulin injected at bedtime may cause hypoglycemia (low blood sugar) in the night in patients with diabetes. The aims of the study are 1) to compare the dynamic characteristics of long-act...
Detailed Description
Patients with advanced type 2 diabetes like those with type 1 diabetes are at risk for defective glucose counterregulation and hypoglycemia unawareness, the components of hypoglycemia-associated auton...
Eligibility Criteria
Inclusion
- Type 2 Diabetes mellitus
- Therapy may be with either insulin alone or in combination with oral anti-diabetic agents
- Metabolic control with HbA1c values \< 10%
Exclusion
- Other than type 2 diabetes
- Pregnancy
- Systemic Corticosteroids, Beta-blockers
- Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematological or other major disease making implementation of the protocol or interpretation of the study results difficult
- History of drug or alcohol abuse
- Impaired renal function (serum creatinine \> 1.3 mg/dl)
Key Trial Info
Start Date :
July 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00468364
Start Date
July 1 2003
End Date
March 1 2006
Last Update
August 30 2007
Active Locations (1)
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1
Clinical Research Unit
Giessen, Germany, 35392