Effect of the DPP-4 Inhibitor Sitagliptin on Islet Function After Mixed Meal in Patients With Type 2 Diabetes
Effect of a Single Dose of the DPP-4 Inhibitor on Islet Function After Igestion of a Standardized Mixed Meal in Subjects With Type 2 Diabetes
1 other identifier
interventional
12
1 country
1
Brief Summary
study hypothesis to examine the acute effects on glycaemia and islet hormone secretion of increased levels of endogenous GLP-1 and GIP on islet cell function in men with type 2 diabetes. To this purpose, a standardized mixed meal test will be ingested with or without concomitant administration of sitagliptin (100mg).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes
Started Jul 2013
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 14, 2013
CompletedFirst Posted
Study publicly available on registry
July 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 15, 2015
March 1, 2015
2.4 years
July 14, 2013
December 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Release of incretins hormones
300 min
Study Arms (2)
Sitagliptin
ACTIVE COMPARATORSitagliptin 100mg is given before meal ingestion
Placebo
PLACEBO COMPARATORPlacebo is given before meal ingestion
Interventions
Sitagliptin 100mg is given before meal ingestion
Eligibility Criteria
You may qualify if:
- Caucasian men with type 2 diabetes diagnosed according to ICD10
- Ongoing treatment with life style adjustment or life style adjustment together with metformin as oral antidiabetic. Metformin therapy should not exceed 2 grams daily
- Age 20-75 years
- HbA1c ≤80 mmol/mol
- BMI: 20-40 kg/m2
You may not qualify if:
- Liver disease or ALAT three times above upper reference range
- Diabetic nephropathy (GFR \< 50 mL/min/1.73 m2 or albuminuria)
- Proliferative diabetic retinopathy
- Treatment with any glucose-lowering medication except metformin
- Previous myocardial infarction, coronary heart disease or insatiable angina pectoris in the last 6 months.
- Previous surgery on the gastrointestinal tract
- Larger surgical intervention during the last 12 weeks
- Treatment with oral steroids or thiazide diuretics
- Treatment with digoxin
- Smokers
- Participation in another study the last 4 weeks
- Paracetamol intolerance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
Study Sites (1)
Department of Clinical Science Lund,Lund University
Lund, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bo Ahren, Professor
Lund University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
July 14, 2013
First Posted
July 17, 2013
Study Start
July 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 15, 2015
Record last verified: 2015-03