Clinical Study Data Request
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Proposal 1593

Title of the Proposed Research

JANUVIA/JANUMET HTA Submission(Germany)

Lead Researcher

Dr. Rainer Woker


MSD Sharp & Dohme GmbH

Funding Source


Potential Conflicts of Interest


Data Sharing Agreement Date

4 November 2016

Lay Summary

Every new drug has to be evaluated by a health technology process. Within this process the new compound will be compared to the standard of care therapy in this indication. In Germany a pharmaceutical company has to submit a dossier for this benefit assessment to the Federal Joint Committee (G-BA). That was done by MSD in 2013 for Sitagliptin in combination with Metformin for the treatment of Type-II-Diabetes.

In the dossier Sitagliptin/Metformin was compared with the appropriate comparator Sulfonylurea/Metformin. The G-BA certified that Sitagliptin/Metformin has an additional benefit for the patients. The G-BA conclusion was restricted in a timely manner till July 1st 2016. The reason for the restriction was missing long term data.

Therefore, MSD Germany resubmitted an updated version of the dossier on July 1. All available evidence was provided to the G-BA. The study HARMONY 3 meets the inclusion criteria for this benefit assessment. On October 4 the benefit assessment was published (Link: It was stated that there is a lack of evidence. Subgroup analyses by metformin dose at baseline for HARMONY 3 are missing.

Therefore we request for data of HARMONY 3 by October 21, 2016. The objective is to show the applicability of the results to the German healthcare context.

Study Data Provided

GSK-GLP112753: A Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Metformin Compared With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo in Subjects With Type 2 Diabetes Mellitus

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.