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

June 23, 2005 updated by: National Center for Research Resources (NCRR)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 2, 2001

First Submitted That Met QC Criteria

April 2, 2001

First Posted (Estimate)

April 3, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

November 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRR-M01RR00042-1749

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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