Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients

P

Profil Institut für Stoffwechselforschung

Status and phase

Completed
Phase 2

Conditions

Pharmacological Action

Treatments

Drug: Placebo
Drug: Sitagliptin 100 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03359590
DPP4-Hypo

Details and patient eligibility

About

Sitagliptin, through its effects on sensitizing alpha-cell sensitivity to glucose, can initiate counter-regulatory glucagon responses at higher glycemic thresholds, thus reducing the number of clinically apparent hypoglycemic episodes, and/or ameliorating the severity of hypoglycemic episodes in the case that they should occur. The endpoints have defined such that consequences of this hypothesis can be measured.

Enrollment

20 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female subject with diabetes mellitus type 2.
  • Age between 18 and 64 years, both inclusive.
  • HbA1c <= 8.5%.
  • Stable treatment with insulin glargine (any dose) and metformin (>= 1500 mg/day or at highest tolerated dose) for at least 3 months prior to inclusion into the trial with or without additional oral glucose-lowering agents (except thiazolidinediones).
  • Considered generally healthy (apart from diabetes mellitus type 2 and associated conditions such as hypertension, hyperlipidaemia and hyperuricaemia) upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator.

Exclusion criteria

  • Known or suspected hypersensitivity to sitagliptin or related products.
  • More than one episode of severe hypoglycaemia with seizure, coma or requiring medical assistance of another person during the past 6 months or hypoglycaemic unawareness as judged by the Investigator.
  • Current or previous treatment (less than 3 months prior to screening) with insulin products other than insulin glargine and/or with Glucagon-like peptide (GLP) 1 receptor agonists and/or with thiazolidinediones.
  • Unwillingness to wash-off any oral glucose-lowering agents other than metformin.

Trial design

20 participants in 2 patient groups, including a placebo group

Sitagliptin arm
Experimental group
Description:
Sitagliptin 100 mg
Treatment:
Drug: Sitagliptin 100 mg
Placebo arm
Placebo Comparator group
Description:
Placebo comparator
Treatment:
Drug: Placebo

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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