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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

NCT ID: NCT01936025

Last Updated: 2017-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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Diabetes mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sitagliptin

Placebo dextromethorphan + sitagliptin 100 mg

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

Dextromethorphan 30 mg + sitagliptin

Dextromethorphan 30 mg + sitagliptin 100 mg

Group Type EXPERIMENTAL

Dextromethorphan

Intervention Type DRUG

Sitagliptin

Intervention Type DRUG

Dextromethorphan 60 mg + sitagliptin

Dextromethorphan 60 mg + sitagliptin 100 mg

Group Type EXPERIMENTAL

Dextromethorphan

Intervention Type DRUG

Sitagliptin

Intervention Type DRUG

Dextromethorphan 90 mg + sitagliptin

Dextromethorphan 90 mg + sitagliptin 100 mg

Group Type EXPERIMENTAL

Dextromethorphan

Intervention Type DRUG

Sitagliptin

Intervention Type DRUG

Dextromethorphan 30 mg + placebo

Dextromethorphan 30 mg + placebo (sitagliptin)

Group Type EXPERIMENTAL

Dextromethorphan

Intervention Type DRUG

Dextromethorphan 60 mg + placebo

Dextromethorphan 60 mg + placebo (sitagliptin)

Group Type EXPERIMENTAL

Dextromethorphan

Intervention Type DRUG

Dextromethorphan 90 mg + placebo

Dextromethorphan 90 mg + placebo (sitagliptin)

Group Type EXPERIMENTAL

Dextromethorphan

Intervention Type DRUG

Placebo

Placebo (dextromethorphan)+ placebo (sitagliptin)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Dextromethorphan

Intervention Type DRUG

Sitagliptin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Profil Institut für Stoffwechselforschung GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alin Stirban, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut für Stoffwechselforschung GmbH

Locations

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Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 26362564 (View on PubMed)

Other Identifiers

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00/0648-DXM2

Identifier Type: -

Identifier Source: org_study_id