Status:
COMPLETED
Sitagliptin and Glucagon Counterregulation
Lead Sponsor:
Lund University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
65-90 years
Phase:
PHASE4
Brief Summary
To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at moderate hypoglycemia in metformin-treated subjects with T2DM
Detailed Description
The glucagon response to mild (3.0 mmol/l) hypoglycemia with and without DPP-4 inhibition by sitagliptin will be evaluated in elderly subjects with metformin treated type 2 diabetes to explore whether...
Eligibility Criteria
Inclusion
- Written consent has been given.
- Patients with metformin treated T2DM (metformin dose \>0,5 g/day and stable during the preceding 3 months)
- Age \>65 years.
- HbA1c 6.0-8.5% (43-67 mmol/mol; inclusive) at visit 1.
- Ability to complete the study
Exclusion
- A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
- Type 2 diabetes, positive GAD antibodies
- eGFR \<60 ml/min
- Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
- Any history of recent (\<2 weeks) recurrent or severe hypoglycemic episodes.
- Liver disease such as cirrhosis or chronic active hepatitis
- History of coronary heart disease or heart failure class III or IV
- Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
- Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (\> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
- Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02256189
Start Date
April 1 2015
End Date
June 1 2017
Last Update
February 20 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Skane University Hospital Malmö
Malmo, Sweden, 20502