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Sponsors and Collaborators: |
University of Giessen Sanofi-Aventis |
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Information provided by: | University of Giessen |
ClinicalTrials.gov Identifier: | NCT00468364 |
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-acting insulin analog glargine with those of NPH insulin and placebo during the night and the early morning hours, 2) investigate differences on glucose metabolism of bedtime glargine versus NPH insulin at induced hypoglycemia.
Condition | Intervention |
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Diabetes |
Drug: insulin glargine Drug: NPH insulin |
Study Type: | Observational |
Study Design: | Natural History, Cross-Sectional, Defined Population, Prospective Study |
Official Title: | Comparison of Carbohydrate Metabolism During the Night and at Hypoglycemia in Type-2 Diabetic Patients Either on Glargine or NPH Insulin |
Enrollment: | 12 |
Study Start Date: | July 2003 |
Study Completion Date: | March 2006 |
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 autonomic failure and the resultant vicious cycle of recurrent iatrogenic hypoglycemia. This may explain why iatrogenic hypoglycemia becomes limiting to glycemic control as patients approach the insulin-deficient end of the spectrum of type 2 diabetes. Compared to Neutral Protamin Hagedorn (NPH) insulin glargine is a new long-acting peakless analogue with lower incidence of nocturnal hypoglycemia having the potential to decrease the frequency of hypoglycemia of insulin therapy. Modern type 2 diabetes therapy guidelines recommend insulin for an increasing population of patients. There is no doubt that type 2 diabetic patients suffer from hypoglycemia under insulin therapy, however it is not clear whether the extensive studies on hypoglycemia in type 1 patients apply also for type 2 diabetes. Recent reports indicate that type 2 diabetic patients of long duration react similarly to a hypoglycemic clamp as type 1 diabetic patients while well controlled type 2 diabetics had even more favorable thresholds for counter-regulatory hormone secretion. On the basis of these considerations the aims of this study are to 1) more precisely define the mechanisms of hypoglycemia in type 2 diabetes, 2) to investigate differences on glucose and lactate metabolism of bedtime NPH insulin versus glargine. To address these objectives we will use the hypoglycemic clamping technique combined with infusion of stable isotopes of glucose and lactate and non-invasive measurement of muscle flow characteristics at hypoglycemia.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | Clamp EC 48/2003 |
Study First Received: | April 30, 2007 |
Last Updated: | August 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00468364 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Hypoglycemia, bedtime insulin, long-acting insulin |
Insulin, Long-Acting Metabolic Diseases Diabetes Mellitus, Type 2 Glargine Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Hypoglycemia Insulin, Isophane Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |