Effect of GLP-1 and GIP on Insulin Secretion in Type-1 Diabetes Mellitus

This study has been completed.
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
First received: January 15, 2008
Last updated: January 20, 2011
Last verified: August 2009
study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified as having no residual beta cell function left.

Condition Intervention
Type-1 Diabetes Mellitus
Other: glucagon like peptide -1
Other: NaCl
Other: glucose dependent insulinotropic polypeptide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effect of GLP-1 and GIP on the Maximal Insulin Secretory Capacity in Type-1 Diabetes Mellitus

Resource links provided by NLM:

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • phase insulin response and phase insulin response measured as incremental area under the curve from 0-10 minutes and incremental area under the curve from 10-45 minutes respectively after iv glucose [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • maximal insulin response defined as mean insulin at time 47 and 49 minutes (2 and 4 minutes after infusion of L-Arginine) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: January 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLP-1
time -30-90 min: Continuous infusion with GLP-1 (1,2pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).
Other: glucagon like peptide -1
continuous infusion 1,2 pmol pr. kg pr minute at 120 minutes
Placebo Comparator: NaCl
time -30-90 min: Continuous infusion with NaCl time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).
Other: NaCl
infusion with NaCl for 120 minutes as placebo-arm
Experimental: GIP
time -30-90 min: Continuous infusion with GIP-1 (3,6pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).
Other: glucose dependent insulinotropic polypeptide
continuous infusion with GIP-1 (3,6pmol/kg/min) at 120 minutes.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 18-60 years
  • Type-1 diabetes diagnosed between 5-40 years of age
  • Normal weight(BMI 18-27),
  • Insulin treatment from time of diagnosis.

Exclusion Criteria:

  • Severe complications to diabetes
  • Abnormal liver or kidney function
  • Haemoglobin below the lower limit
  • Macroalbuminuria
  • Systemic disease
  • Pregnancy.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00603031

Dept. of Endocrinology, Hvidovre Hospital
Copenhagen, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Principal Investigator: Urd Kielgast, MD unafilliated
  More Information

Responsible Party: Urd Kielgast,MD, Urd Kielgast, MD
ClinicalTrials.gov Identifier: NCT00603031     History of Changes
Other Study ID Numbers: H-D-2007-0076  2008-000305-11 
Study First Received: January 15, 2008
Last Updated: January 20, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Gastric Inhibitory Polypeptide
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016