Sitagliptin and Glucagon Counterregulation

NCT02256189 | Completed Phase 4 Results

• 1 other identifier: 300A
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at moderate hypoglycemia in metformin-treated subjects with T2DM

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Glucagon Counterregulation to Hypoglycemia

  Change in plasma glucagon to insulin-induced hypoglycemia after four weeks of treatment with sitagliptin and placebo

  Four weeks treatment

Study Arms (2)

Sitagliptin first, then placebo

OTHER

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

Drug: Sitagliptin

Placebo first, then sitagliptin

OTHER

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

Drug: Placebo

Interventions

Sitagliptin DRUG

Sitagliptin 100 mg daily

Sitagliptin first, then placebo

Placebo DRUG

Placebo one tablet daily

Placebo first, then sitagliptin

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Skane University Hospital Malmö

Malmo, 20502, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Professor Bo Ahrén
• Organization: Lund University

Bo.Ahren@med.lu.se

+46462220758

Study Officials

• Bo Ahrén, MD, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 3, 2014
• Study Start: April 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 20, 2019
• Results First Posted: February 20, 2019

Record last verified: 2018-10

Locations

SE (1)