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NNC 90-1170 Mechanism of Action: A Double-Blind, Randomized, Single-Center, Placebo-Controlled, Crossover Study to Examine Beta-Cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00013910
First received: April 2, 2001
Last updated: June 23, 2005
Last verified: November 2001

April 2, 2001
June 23, 2005
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Complete list of historical versions of study NCT00013910 on ClinicalTrials.gov Archive Site
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NNC 90-1170 Mechanism of Action: A Double-Blind, Randomized, Single-Center, Placebo-Controlled, Crossover Study to Examine Beta-Cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes
NNC 90-1170 Mechanism of Action: A Double-Blind, Randomized, Single-Center, Placebo-Controlled, Crossover Study to Examine Beta-Cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes

The purpose of this research study is to investigate the mechanism of action of a new investigational medication (drug), NNC 90-1170, which is being developed for the treatment of type 2 diabetes (adult onset type of diabetes.

NNC 90-1170 is a modified form of a hormone, Glucagon-Like Peptide 1 (or GLP-1), which is important for controlling insulin levels. Insulin, another hormone, is also important for controlling blood glucose levels, which are higher than normal in people who have type 2 diabetes. This study will measure the effect of NNC 90-1170, active investigational drug, to cause insulin to be released from the pancreas in response to increasing blood glucose concentrations. These results will be compared to that of a group of healthy volunteers of similar age and body weight who do not have diabetes. Also, various other hormones and substances that are known to control blood sugar will be measured in blood samples that will be drawn.

One dose of NNC 90-1170 will be given to subjects with type 2 diabetes only in this study, and the effects of this dose will be compared to a placebo (inactive substance that looks like the active drug). This is a crossover study, which means that subjects will be treated both with NNC 90-1170 and with placebo. The order in which subjects will receive the treatments will be determined by chance (randomly).

The study will be conducted as a so-called "double-blind" study, meaning that neither subjects nor study doctors will know the order in which subjects will be given each treatment until the study is over.

The study will include approximately 15 healthy volunteers and 15 volunteers with type 2 diabetes, and it will be conducted at 1 clinic (the University of Michigan Health System) in the United States.

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Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Non-Insulin-Dependent
Drug: NNC 90-1170
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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Inclusion criteria:

Subjects with Type 2 Diabetes

  1. Signed and dated informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that would not have been performed during normal management of the subject.
  2. Subjects diagnosed with type 2 diabetes according to the American Diabetes Association (ADA) criteria (6): fasting plasma glucose ?126 mg/dL (7.0 mmol/L) or 2-hour plasma glucose ? 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test (OGTT).
  3. Subjects with type 2 diabetes either newly diagnosed with at least 2 months of diet or on oral anti-diabetic monotherapy for at least 3 months.
  4. Age 30-75 years inclusive. Body Mass Index 24 to 35 kg/m2 inclusive.

Healthy Volunteers

  1. The subject must give signed and dated informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during normal management of the subject.
  2. Age 30-75 years inclusive.
  3. Body Mass Index 24 to 35 kg/m2 inclusive. Must meet the ADA criteria for normal glucose tolerance (6): fasting plasma glucose below 110 mg/dL (6.1 mmol/L) and 2-hour plasma glucose < 140 mg/mL (7.8 mmol/L) during an OGTT.
Both
30 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00013910
NCRR-M01RR00042-1749
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National Center for Research Resources (NCRR)
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National Center for Research Resources (NCRR)
November 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP