Type 2 Diabetes MellitusPhase 2DXM2NCT01936025
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
A Phase 2 study testing Dextromethorphan and Sitagliptin in people with Type 2 Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Dextromethorphan and Sitagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Dextromethorphan, Sitagliptin, Placebo
- Keywords
- Diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextromethorphanDrug
SitagliptinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Active comparator | Placebo dextromethorphan + sitagliptin 100 mg Receives: Drug: Sitagliptin |
| Dextromethorphan 30 mg + sitagliptin | Experimental | Dextromethorphan 30 mg + sitagliptin 100 mg Receives: Drug: Dextromethorphan; Drug: Sitagliptin |
| Dextromethorphan 60 mg + sitagliptin | Experimental | Dextromethorphan 60 mg + sitagliptin 100 mg Receives: Drug: Dextromethorphan; Drug: Sitagliptin |
| Dextromethorphan 90 mg + sitagliptin | Experimental | Dextromethorphan 90 mg + sitagliptin 100 mg Receives: Drug: Dextromethorphan; Drug: Sitagliptin |
| Dextromethorphan 30 mg + placebo | Experimental | Dextromethorphan 30 mg + placebo (sitagliptin) Receives: Drug: Dextromethorphan |
| Dextromethorphan 60 mg + placebo | Experimental | Dextromethorphan 60 mg + placebo (sitagliptin) Receives: Drug: Dextromethorphan |
| Dextromethorphan 90 mg + placebo | Experimental | Dextromethorphan 90 mg + placebo (sitagliptin) Receives: Drug: Dextromethorphan |
| Placebo | Placebo comparator | Placebo (dextromethorphan)+ placebo (sitagliptin) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
lowest dose of DXM
To find the lowest dose of DXM that, compared to placebo, exerts BG lowering effects related to an OGTT
Measured: up to 4 hours after study drug administration
Secondary outcomes (1)
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
Measured: up to 4 hours after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alin Stirban, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936025
- Sponsor's protocol ID
- 00/0648-DXM2
- Acronym
- DXM2
- Status last verified
- Nov 2017
- First submitted
- 28 Aug 2013
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26362564
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01936025
- Acronym / sponsor ID
- DXM2 / 00/0648-DXM2
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Active comparator | Drug: SitagliptinPlacebo dextromethorphan + sitagliptin 100 mg |
| Dextromethorphan 30 mg + sitagliptin | Experimental | Drug: Dextromethorphan, Drug: SitagliptinDextromethorphan 30 mg + sitagliptin 100 mg |
| Dextromethorphan 60 mg + sitagliptin | Experimental | Drug: Dextromethorphan, Drug: SitagliptinDextromethorphan 60 mg + sitagliptin 100 mg |
| Dextromethorphan 90 mg + sitagliptin | Experimental | Drug: Dextromethorphan, Drug: SitagliptinDextromethorphan 90 mg + sitagliptin 100 mg |
| Dextromethorphan 30 mg + placebo | Experimental | Drug: DextromethorphanDextromethorphan 30 mg + placebo (sitagliptin) |
| Dextromethorphan 60 mg + placebo | Experimental | Drug: DextromethorphanDextromethorphan 60 mg + placebo (sitagliptin) |
| Dextromethorphan 90 mg + placebo | Experimental | Drug: DextromethorphanDextromethorphan 90 mg + placebo (sitagliptin) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (dextromethorphan)+ placebo (sitagliptin) |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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
1 secondary outcome
additive BG lowering effects
Time frame: up to 4 hours after study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Derived from this study: PubMed 26362564Marquard 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.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alin Stirban, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dextromethorphan and Sitagliptin in people with Type 2 Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lowest dose of DXM (time frame: up to 4 hours after study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01936025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.