Empagliflozin/metformin Hydrochloride in Diabetes Mellitus, Type 2: NCT07771010 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 18 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 4
Clinical phase
Recruiting
Recruitment status
54
Planned enrollment
2027-12-31
Primary-completion proxy
Executive view
NCT07771010 evaluates Empagliflozin/metformin Hydrochloride in Diabetes Mellitus, Type 2. The disclosed sponsor is UMC Ljubljana, the design is Interventional, and the geographic footprint is Slovenia. The first listed primary endpoint is Change in skeletal muscle mitochondrial oxidative capacity, assessed over Baseline, Day 14, Month 1, Month 3, and Month 6.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07771010 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Diabetes Mellitus, Type 2 landscape. Drug & Asset MCP drug_fetch was queried for Empagliflozin/metformin Hydrochloride, while Company & Deal Intelligence MCP organization_fetch was queried for UMC Ljubljana.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07771010 | Empagliflozin/metformin Hydrochloride | Phase 4 / Recruiting | UMC Ljubljana | Slovenia | Change in skeletal muscle mitochondrial oxidative capacity Baseline, Day 14, Month 1, Month 3, and Month 6 | 2027-12-31 |
| NCT07767552 | Mazdutide | Not Applicable / Not yet recruiting | Sun Yat-Sen University | China | Proportion of Participants Achieving Normal Glucose Regulation (NGR) at Week 44 Baseline, 44 weeks | 2028-08-30 |
| NCT07768280 | Metformin Hydrochloride | Not Applicable / Not yet recruiting | Jiangxi University of Traditional Chinese Medicine | China | Complete discontinuation rate of oral hypoglycemic drugs At 48 weeks of follow-up | 2028-02-01 |
| NCT07765511 | Macupatide | Phase 1 / Not yet recruiting | Eli Lilly & Co. | Japan | Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to… End of Study (Week 25) | 2027-06-01 |
| NCT07754461 | Survodutide | Phase 3 / Recruiting | Boehringer Ingelheim GmbH | New Zealand, Canada, United States, Australia, India | Absolute change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline to Week 41 At baseline and Week 41. | 2028-01-17 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT07771010 is a Phase 4, recruiting study with 54 planned participants. Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment.
The primary endpoint is “Change in skeletal muscle mitochondrial oxidative capacity” over “Baseline, Day 14, Month 1, Month 3, and Month 6.” The retrieved endpoint description is: Skeletal muscle mitochondrial oxidative capacity will be assessed non-invasively using near-infrared spectroscopy (NIRS) over the flexor digitorum superficialis muscle of the non-dominant forearm. The recovery rate of tissue oxygen saturation (StO2) following submaximal muscular exercise and repeated brief arterial occlusions will be used as an index of mitochondrial oxidative capacity. This outcome will be compared across the three treatment arms to test the hypotheses that empagliflozin increases skeletal muscle oxidative capacity, that metformin does not alter oxidative capacity, and that combination therapy….
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 54 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Diabetes Mellitus, Type 2. These records do not establish direct evidence for NCT07771010 unless the registration number matches.
A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Oral Semaglutide in Adult Participants With Type 2 Diabet…
Phase 3; n=1698; Change From Baseline in Hemoglobin A1c (HbA1c) [Non-inferiority of 36 mg Orforglipron Versus 14 mg Semaglutide and 12 mg Orforglipron Versus 7 mg Semaglutide](Least Squares Mean): Least Squares Mean difference = -0.71(95% CI, -0.86 to -0.55), P-Value = <.001; Least Squares Mean difference = -0.79(95% CI, -0.96 to -0.62), P-Value = <.001; Change From Baseline in Hemoglobin A1c (HbA1c) [Non-inferiority of 36 mg Orforg… Source: https://clinicaltrials.gov/ct2/show/results/NCT06045221
A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhib…
Phase 2; n=39; Absolute Change in HbA1c(Least Squares Mean) = 0.16 percentage of glycosylated hemoglobin (95% Confidence Interval, -0.32 to 0.63); Absolute Change in HbA1c(Least Squares Mean) = -1.11 percentage of glycosylated hemoglobin (95% Confidence Interval, -1.6 to -0.62) Source: https://clinicaltrials.gov/ct2/show/results/NCT05232071
A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweigh…
Phase 3; n=1613; Percent Change From Baseline in Body Weight(Least Squares Mean) = -2.21 percent change (Standard Error, 0.215); Percent Change From Baseline in Body Weight(Least Squares Mean) = -5.50 percent change (Standard Error, 0.356) Source: https://clinicaltrials.gov/ct2/show/results/NCT05872620
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Empagliflozin/metformin Hydrochloride is indexed as Small molecule drug with PRKAB1 x SGLT2 biology and a global stage of Approved. The asset profile lists Boehringer Ingelheim GmbH as an originator or developer.
UMC Ljubljana is indexed in Slovenia. The organization record is used to resolve sponsor identity. The record lists an unreported number of development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Empagliflozin/metformin Hydrochloride is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07771010
Protocol source: https://clinicaltrials.gov/study/NCT07771010
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 18 September 2026.
Empagliflozin/metformin Hydrochloride in Diabetes Mellitus, Type 2 is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Change in skeletal muscle mitochondrial oxidative capacity and 2027-12-31 the leading decision points.
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