Comparison of Insulin Glargine and NPH Insulin at Night and at Hypoglycemia in Type 2 Diabetes (ClampHOE901)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00468364
Recruitment Status : Completed
First Posted : May 2, 2007
Last Update Posted : August 30, 2007
Information provided by:
University of Giessen

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-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 or disease Intervention/treatment
Diabetes Drug: insulin glargine Drug: NPH insulin

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 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.

Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Comparison of Carbohydrate Metabolism During the Night and at Hypoglycemia in Type-2 Diabetic Patients Either on Glargine or NPH Insulin
Study Start Date : July 2003
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00468364

Clinical Research Unit
Giessen, Germany, 35392
Sponsors and Collaborators
University of Giessen
Principal Investigator: Thomas Linn, MD Justus Liebig University

Publications: Identifier: NCT00468364     History of Changes
Other Study ID Numbers: Clamp EC 48/2003
First Posted: May 2, 2007    Key Record Dates
Last Update Posted: August 30, 2007
Last Verified: August 2007

Keywords provided by University of Giessen:
Hypoglycemia, bedtime insulin, long-acting insulin

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin Glargine
Insulin, Isophane
Isophane Insulin, Human
Hypoglycemic Agents
Physiological Effects of Drugs