DXM2: 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

• Sponsor: Profil Institut für Stoffwechselforschung GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01936025
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 8
• Duration (Months): 6
• Patients Per Site Per Month: 5.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Dextromethorphan; Drug: Sitagliptin; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

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: Dextromethorphan; Drug: Sitagliptin
Experimental: Dextromethorphan 60 mg + sitagliptin Dextromethorphan 60 mg + sitagliptin 100 mg	Drug: Dextromethorphan; Drug: Sitagliptin
Experimental: Dextromethorphan 90 mg + sitagliptin Dextromethorphan 90 mg + sitagliptin 100 mg	Drug: Dextromethorphan; Drug: Sitagliptin
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

Outcome Measures

Primary Outcome Measures

1. lowest dose of DXM [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

Secondary Outcome Measures

1. additive BG lowering effects [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Profil Institut für Stoffwechselforschung GmbH	Neuss		Germany	41460

Sponsors and Collaborators

• Profil Institut für Stoffwechselforschung GmbH

Investigators

• Principal Investigator: Alin Stirban, MD, Profil Institut für Stoffwechselforschung GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Profil Institut für Stoffwechselforschung GmbH
• ClinicalTrials.gov Identifier: NCT01936025
• Other Study ID Numbers: 00/0648-DXM2
• First Posted: Sep 5, 2013
• Last Update Posted: Nov 7, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by Profil Institut für Stoffwechselforschung GmbH: Diabetes mellitus
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Sitagliptin Phosphate; Dextromethorphan

Study Results

No Results Posted as of Nov 7, 2017