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Completed

NCT Number: NCT02256189

Sitagliptin and Glucagon Counterregulation

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Skane University Hospital Malmö

Malmö, 20502, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Sitagliptin

Drug

Sitagliptin 100 mg daily

Placebo

Drug

Placebo one tablet daily

Primary outcomes

  1. Glucagon Counterregulation to Hypoglycemia

    Time frame: Four weeks treatment

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

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

The Effect of Sitagliptin on Glucagon Counterregulation and Incretin Hormones During Mild Hypoglycemia in Elderly Patients With Metformin-treated Type 2 Diabetes

Acronym: SITACLAMP

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 3, 2014
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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