Comparison of Insulin Glargine and NPH Insulin at Night and at Hypoglycemia in Type 2 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00468364
• Date of registration: 30/04/2007
• Primary sponsor: University of Giessen
• Public title: Comparison of Insulin Glargine and NPH Insulin at Night and at Hypoglycemia in Type 2 Diabetes ClampHOE901
• Scientific title: Comparison of Carbohydrate Metabolism During the Night and at Hypoglycemia in Type-2 Diabetic Patients Either on Glargine or NPH Insulin
• Date of first enrolment: July 2003
• Target sample size: 12
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00468364
• Study type: Observational
• Study design: Observational Model: Defined Population, Observational Model: Natural History, Time Perspective: Cross-Sectional, Time Perspective: Prospective

Countries of recruitment

Germany

Contacts

• Name: Thomas Linn, MD
• Affiliation: Justus Liebig University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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)



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes

Intervention(s)

Drug: insulin glargine

Drug: NPH insulin

Secondary ID(s)

Clamp EC 48/2003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi-Aventis