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

Type 2 Diabetes Mellitus Clinical Trial

— DXM2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936025
• Other study ID #: 00/0648-DXM2
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2013
• Last updated: November 6, 2017
• Start date: October 2013
• Est. completion date: April 2014

Study information

• Verified date: November 2017
• Source: Profil Institut für Stoffwechselforschung GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dextromethorphan

• Sitagliptin

• Placebo

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Profil Institut für Stoffwechselforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	additive BG lowering effects	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