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Trial record 24 of 13174 for:    "Diabetes Mellitus"

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)

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ClinicalTrials.gov Identifier: NCT01936025
Recruitment Status : Completed
First Posted : September 5, 2013
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH

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 Type : Interventional  (Clinical Trial)
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 : October 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014


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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936025


Locations
Germany
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT01936025     History of Changes
Other Study ID Numbers: 00/0648-DXM2
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

Keywords provided by Profil Institut für Stoffwechselforschung GmbH:
Diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Dextromethorphan
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents