NCT01048268

Brief Summary

The purpose of this study is to determine whether glucose-dependent insulinotropic polypeptide (GIP) has a stabilizing function on the blood glucose

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_1 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 14, 2015

Status Verified

July 1, 2015

Enrollment Period

4.3 years

First QC Date

January 12, 2010

Last Update Submit

July 10, 2015

Conditions

Diabetes Mellitus

Keywords

T1DMT2DMGIPGlucose-dependent insulinotropic polypeptideIncretin

Outcome Measures

Primary Outcomes (1)

  • The difference in glucagon secretion quantified as the difference in plasma glucagon concentration and incremental baseline-subtracted area under the curve (AUC) for plasma glucagon

    -10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit

Secondary Outcomes (1)

  • The difference between the amount of infused glucose and the insulin responses

    will be measured at each visit

Study Arms (3)

Healthy volunteers

EXPERIMENTAL
Drug: glucose-dependent insulinotropic polypeptideDrug: Placebo

Patients with Type 1 diabetes mellitus

EXPERIMENTAL
Drug: glucose-dependent insulinotropic polypeptideDrug: Placebo

Patients with type 2 diabetes mellitus

EXPERIMENTAL
Drug: glucose-dependent insulinotropic polypeptideDrug: Placebo

Interventions

glucose-dependent insulinotropic polypeptideDRUG

For the first 20 min of the experiment the volunteers will receive GIP at 4 pmol/kg body weight. For the following 40 minutes the volunteers will receive 2 pmol/kg body weight

Healthy volunteersPatients with Type 1 diabetes mellitusPatients with type 2 diabetes mellitus
PlaceboDRUG

copy GIP infusion rates

Healthy volunteersPatients with Type 1 diabetes mellitusPatients with type 2 diabetes mellitus

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caucasians with T1DM (diagnosed according to WHO's criteria) without residual beta cell function (arginine test without increase in c-peptide) in treatment with long acting insulin OR
  • Caucasians with non-insulin treated T2DM (diagnosed according to WHO's criteria) OR
  • Caucasians without first degree relative with diabetes mellitus, with normal fasting plasma glucose and glucose tolerance along with negative islet and GAD-65 autoantibodies AND
  • Normal hemoglobin
  • Informed consent

You may not qualify if:

  • Unwillingness to participate or the wish to leave the present study
  • HbA1c \> 9 %
  • Liver disease (ALAT or ASAT \> 2 times normal value)
  • Diabetic nephropathy (serum creatinin \> 130 microM and/or albuminury)
  • Proliferative diabetic retinopathy (anamnetic)
  • Atherosclerotic heart disease or heart failure (NYHA group III and IV)
  • Anemia
  • Treatment with medicine which cannot be paused for 12 hours
  • Pregnancy and/or breast feeding
  • Fasting plasma glucose \> 15 mM on the day of the experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine F' laboratory

Hellerup, Copenhagen County, 2900, Denmark

Location

Related Publications (1)

  • Veedfald S, Vedtofte L, Skov-Jeppesen K, Deacon CF, Hartmann B, Vilsboll T, Knop FK, Christensen MB, Holst JJ. Glucose-Dependent Insulinotropic Polypeptide Is a Pancreatic Polypeptide Secretagogue in Humans. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz097. doi: 10.1210/clinem/dgz097.

    PMID: 31665480DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Incretins

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Mikkel Christensen, MD

    Bispebjerg Hospital, Copenhagen

    PRINCIPAL INVESTIGATOR

  • Filip K Knop, MD PhD

    Diabetes Research Division, Department of Internal Medicine F, Gentofte Hospital, University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 13, 2010

Study Start

December 1, 2009

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 14, 2015

Record last verified: 2015-07

Locations

DK(1)