A Phase 2 interventional study of Dextromethorphan and Sitagliptin in Type 2 Diabetes Mellitus, sponsored by Profil Institut für Stoffwechselforschung GmbH. Completed at 1 site in Germany. Open to male participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-11-07.
Sponsored by Profil Institut für Stoffwechselforschung GmbH · Phase 2, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 34 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Profil Institut für Stoffwechselforschung GmbH is the lead sponsor of 24 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Placebo dextromethorphan + sitagliptin 100 mg
Drug: Sitagliptin
Dextromethorphan 30 mg + sitagliptin 100 mg
Drug: Dextromethorphan · Drug: Sitagliptin
Dextromethorphan 60 mg + sitagliptin 100 mg
Drug: Dextromethorphan · Drug: Sitagliptin
Dextromethorphan 90 mg + sitagliptin 100 mg
Drug: Dextromethorphan · Drug: Sitagliptin
Dextromethorphan 30 mg + placebo (sitagliptin)
Drug: Dextromethorphan
Dextromethorphan 60 mg + placebo (sitagliptin)
Drug: Dextromethorphan
Dextromethorphan 90 mg + placebo (sitagliptin)
Drug: Dextromethorphan
Placebo (dextromethorphan)+ placebo (sitagliptin)
Drug: Placebo
lowest dose of DXM
To find the lowest dose of DXM that, compared to placebo, exerts BG lowering effects related to an OGTT
Time frame: up to 4 hours after study drug administration
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
Time frame: up to 4 hours after study drug administration
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Profil Institut für Stoffwechselforschung GmbH