A Study to Investigate the Glucose Lowering Effects of Dextromethorphan Alone or in Combination With Sitagliptin in Subjects With Type 2 Diabetes Mellitus (T2DM) After an Oral Glucose Tolerance Test (DXM2)

November 6, 2017 updated by: Profil Institut für Stoffwechselforschung GmbH

A Phase IIa, Dose-finding, Double-blind, Placebo-controlled, Double-dummy, Randomized, Eightfold Cross-over Study to Investigate the Glucose Lowering Effects of Dextromethorphan Alone or in Combination With Sitagliptin in Subjects With Type 2 Diabetes Mellitus (T2DM) After an Oral Glucose Tolerance Test

The study has a randomized, double-blind, placebo-controlled, double dummy and eight-way cross-over design. Males with T2DM on a stable metformin monotherapy will be screened for participation in the study. Eligible subjects will be randomized to receive DXM 30 mg, DXM 60 mg, DXM 90 mg alone or in combination with sitagliptin 100 mg, sitagliptin 100 mg alone, or placebo (for DXM and sitagliptin) on in total eight treatment days. An OGTT will be started 1 hour after study drug administration and blood glucose will be measured over the next 4 hours. There will be a 3 to 14-day washout period between doses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is performed to determine the optimal dose of DXM that, compared to placebo, decreases glucose excursions following an OGTT. Doses of 30 mg, 60 mg and 90 mg DXM were chosen. Since DXM 60 mg was effective in the previous study in increasing insulin secretion, this dose will be kept. A lower dose (30 mg) will be given to see whether effects on insulin secretion are present also at lower doses and then translate into a BG lowering action. A higher dose (90 mg) will be added to see whether this way an effect on glucose excursion reduction occurs following an OGTT, (like previously demonstrated with 270 mg DXM) that can be related to an increase of insulin secretion.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Signed and dated written informed consent obtained before any study-related activities
  2. Male subjects with a diagnosis of type 2 diabetes mellitus according to ADA criteria at least 4 months prior to screening
  3. Medical history without major pathology (with the exception of type 2 diabetes)
  4. On a stable regimen of metformin monotherapy for at least 3 months
  5. Aged between 45 and 70 years of age, both inclusive
  6. Body mass index (BMI) between 25 and 35kg/m2, both inclusive

Exclusion Criteria:

  1. Subjects with type 1 diabetes, MODY or secondary forms of diabetes such as due to pancreatitis
  2. History of pancreatitis
  3. Current or previous treatment with insulin therapy
  4. Treatment with any hypoglycemic medication other than metformin within the three months prior to screening
  5. Mean QTc> 450 msec

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Sitagliptin
Placebo dextromethorphan + sitagliptin 100 mg
Drug: Sitagliptin
EXPERIMENTAL: Dextromethorphan 30 mg + sitagliptin
Dextromethorphan 30 mg + sitagliptin 100 mg
Drug: Sitagliptin
Drug: Dextromethorphan
EXPERIMENTAL: Dextromethorphan 60 mg + sitagliptin
Dextromethorphan 60 mg + sitagliptin 100 mg
Drug: Sitagliptin
Drug: Dextromethorphan
EXPERIMENTAL: Dextromethorphan 90 mg + sitagliptin
Dextromethorphan 90 mg + sitagliptin 100 mg
Drug: Sitagliptin
Drug: Dextromethorphan
EXPERIMENTAL: Dextromethorphan 30 mg + placebo
Dextromethorphan 30 mg + placebo (sitagliptin)
Drug: Dextromethorphan
EXPERIMENTAL: Dextromethorphan 60 mg + placebo
Dextromethorphan 60 mg + placebo (sitagliptin)
Drug: Dextromethorphan
EXPERIMENTAL: Dextromethorphan 90 mg + placebo
Dextromethorphan 90 mg + placebo (sitagliptin)
Drug: Dextromethorphan
PLACEBO_COMPARATOR: Placebo
Placebo (dextromethorphan)+ placebo (sitagliptin)
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lowest dose of DXM
Time Frame: up to 4 hours after study drug administration
To find the lowest dose of DXM that, compared to placebo, exerts BG lowering effects related to an OGTT
up to 4 hours after study drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
additive BG lowering effects
Time Frame: up to 4 hours after study drug administration
To demonstrate whether the administration of DXM on top of sitagliptin exerts additive BG lowering effects related to an OGTT as compared to sitagliptin alone and DXM alone
up to 4 hours after study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Profil Institut für Stoffwechselforschung GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

September 2, 2013

First Posted (ESTIMATE)

September 5, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00/0648-DXM2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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