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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


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.


Minimum age: 65 Years. Maximum age: 80 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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