Sitagliptin and Glucagon Counterregulation

NCT ID: NCT02256189

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-06-30

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 DPP-4 inhibition affects glucagon counter-regulation.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Sitagliptin first, then placebo

Sitagliptin treatment for four weeks, then washout for four weeks, then placebo for four weeks

Group Type: OTHER

Sitagliptin

Intervention Type: DRUG

Sitagliptin 100 mg daily

Placebo first, then sitagliptin

Placebo for four weeks, then washout for four weeks, then sitagliptin for four weeks

Group Type: OTHER

Placebo

Intervention Type: DRUG

Placebo one tablet daily

Interventions

Sitagliptin

Sitagliptin 100 mg daily

Intervention Type: DRUG

Placebo

Placebo one tablet daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Written consent has been given.

2. Patients with metformin treated T2DM (metformin dose >0,5 g/day and stable during the preceding 3 months)

3. Age >65 years.

4. HbA1c 6.0-8.5% (43-67 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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Bo Ahren

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bo Ahrén, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Skane University Hospital Malmö

Malmo, , Sweden

Countries

Sweden

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

300A

Identifier Type: -

Identifier Source: org_study_id