Sitagliptin and Glucagon Counterregulation
Information source: Lund University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Sitagliptin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Lund University Official(s) and/or principal investigator(s):
Bo Ahrén, MD, PhD, Principal Investigator, Affiliation: Lund University
Overall contact:
Bo Ahrén, MD, PhD, Phone: +46462220758, Email: Bo.Ahren@med.lu.se
Summary
To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at
moderate hypoglycemia in metformin-treated subjects with T2DM
Clinical Details
Official title: The Effect of Sitagliptin on Glucagon Counterregulation and Incretin Hormones During Mild Hypoglycemia in Elderly Patients With Metformin-treated Type 2 Diabetes
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Glucagon counterregulation to hypoglycemia
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 DPP-4 inhibition affects glucagon counter-regulation.
Eligibility
Minimum age: 65 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Written consent has been given.
2. Patients with metformin treated T2DM (metformin dose >1. 0 g/day and stable during the
preceding 3 months)
3. Age >65 years.
4. HbA1c 6. 5-8. 5% (48-67 mmol/mol; inclusive) at visit 1.
5. Ability to complete the study
Exclusion Criteria:
1. A history of any secondary forms of diabetes, e. g., Cushing's syndrome and
acromegaly.
2. Type 2 diabetes, positive GAD antibodies
3. eGFR <60 ml/min
4. Acute infections which may affect blood glucose control within 4 weeks prior to visit
1
5. Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.
6. Liver disease such as cirrhosis or chronic active hepatitis
7. History of coronary heart disease or heart failure class III or IV
8. 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.
9. Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment
(> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
10. Use of other investigational drugs at visit 1 or within 30 days of visit 1,
unsuitable for the study
Locations and Contacts
Bo Ahrén, MD, PhD, Phone: +46462220758, Email: Bo.Ahren@med.lu.se Additional Information
Starting date: November 2014
Last updated: October 6, 2014
|
