- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01219400
Vildagliptin and the Glucagon Response to Hypoglycemia in Insulin-Treated Patients With Type 2 Diabetes
September 29, 2014 updated by: Bo Ahren, Lund University
Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Insulin-treated Patients With Type 2 Diabetes
The purpose of this study is to explore whether the novel therapy of type 2 diabetes, vildagliptin, which inhibits dipeptidyl peptidase-4 (DPP-4), affects glucagon counterregulation during hypoglycemia in insulin-treated patients with type 2 diabetes.
Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter hypoglycemia is induced under standardized conditions, and the glucagon response is determined, and compared to that after a month of placebo treatment.
Study Overview
Detailed Description
Vildagliptin is an inhibitor of dipeptidyl peptidase-4 (DPP-4) and inhibits glucagon secretion and stimulates insulin secretion.
This improves glycemia in subjects with type 2 diabetes with a very low risk for hypoglycemia.
If hypoglycemia nevertheless develops, it is important that vildagliptin under such conditions does not inhibit glucagon secretion, since that would aggravate the hypoglycemia.
It was indeed previously demonstrated in type 2 diabetes that vildagliptin dos not inhibit glucagon secretion during hypoglycemia.
This study explores whether vildagliptin affects glucagon counterregulation during hypoglycemia in insulin-treated patients of type 2 diabetes.
Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter hypoglycemia is induced under standardized conditions, and the glucagon response is determined, and compared to that after a month of placebo treatment.
The hypoglycemia is induced bvy a standardized clamp procedure.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 4
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
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Lund, Sweden, 22184
- Lund University
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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
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 2 diabetes
- Insulin treatment
- Age >18 years
- HbA1c <=8.5%
Exclusion Criteria:
- Pregnancy
- Lactation
- Acute infection
- Liver disease
- Treatment with cortisol
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: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Vildagliptin
Vildagliptin (50 mg BID) given for four weeks
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Vildagliptin (50 mg BID) given for four weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucagon response to hypoglycemia
Time Frame: 45 min
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Change in glucagon from before hypoglycemia clamp until after 45 min
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45 min
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Catecholamine response to hypoglycemia
Time Frame: 45 min
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Change in catecholamines from before hypoglycemic clamp to 45 min
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45 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Bo Ahrén, MD, PhD, Lund University
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 Major Dates
Study Start
January 1, 2012
Primary Completion (ACTUAL)
October 1, 2013
Study Completion (ACTUAL)
December 1, 2013
Study Registration Dates
First Submitted
October 12, 2010
First Submitted That Met QC Criteria
October 12, 2010
First Posted (ESTIMATE)
October 13, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
September 30, 2014
Last Update Submitted That Met QC Criteria
September 29, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemia
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Vildagliptin
Other Study ID Numbers
- 103
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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