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

NCT01936025 | Completed Phase 2

• 1 other identifier: 00/0648-DXM2
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• lowest dose of DXM

  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 Outcomes (1)

• additive BG lowering effects

  up to 4 hours after study drug administration

Study Arms (8)

Sitagliptin

ACTIVE COMPARATOR

Placebo dextromethorphan + sitagliptin 100 mg

Drug: Sitagliptin

Dextromethorphan 30 mg + sitagliptin

EXPERIMENTAL

Dextromethorphan 30 mg + sitagliptin 100 mg

Drug: Dextromethorphan; Drug: Sitagliptin

Dextromethorphan 60 mg + sitagliptin

EXPERIMENTAL

Dextromethorphan 60 mg + sitagliptin 100 mg

Drug: Dextromethorphan; Drug: Sitagliptin

Dextromethorphan 90 mg + sitagliptin

EXPERIMENTAL

Dextromethorphan 90 mg + sitagliptin 100 mg

Drug: Dextromethorphan; Drug: Sitagliptin

Dextromethorphan 30 mg + placebo

EXPERIMENTAL

Dextromethorphan 30 mg + placebo (sitagliptin)

Drug: Dextromethorphan

Dextromethorphan 60 mg + placebo

EXPERIMENTAL

Dextromethorphan 60 mg + placebo (sitagliptin)

Drug: Dextromethorphan

Dextromethorphan 90 mg + placebo

EXPERIMENTAL

Dextromethorphan 90 mg + placebo (sitagliptin)

Drug: Dextromethorphan

Placebo

PLACEBO COMPARATOR

Placebo (dextromethorphan)+ placebo (sitagliptin)

Drug: Placebo

Interventions

Dextromethorphan DRUG

Dextromethorphan 30 mg + placebo; Dextromethorphan 30 mg + sitagliptin; Dextromethorphan 60 mg + placebo; Dextromethorphan 60 mg + sitagliptin; Dextromethorphan 90 mg + placebo; Dextromethorphan 90 mg + sitagliptin

Sitagliptin DRUG

Dextromethorphan 30 mg + sitagliptin; Dextromethorphan 60 mg + sitagliptin; Dextromethorphan 90 mg + sitagliptin; Sitagliptin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Profil Institut für Stoffwechselforschung GmbH: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Related Publications (1)

• Marquard J, Stirban A, Schliess F, Sievers F, Welters A, Otter S, Fischer A, Wnendt S, Meissner T, Heise T, Lammert E. Effects of dextromethorphan as add-on to sitagliptin on blood glucose and serum insulin concentrations in individuals with type 2 diabetes mellitus: a randomized, placebo-controlled, double-blinded, multiple crossover, single-dose clinical trial. Diabetes Obes Metab. 2016 Jan;18(1):100-3. doi: 10.1111/dom.12576. Epub 2015 Oct 26.

  PMID: 26362564 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Dextromethorphan; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Pyrazines

Study Officials

• Alin Stirban, MD

  Profil Institut für Stoffwechselforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 5, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 7, 2017

Record last verified: 2017-11

Locations

DE (1)