Summary
Metformin Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Type 2 Diabetes would be drug repurposing rather than first-in-human development. This does not mean it is approved for Type 2 Diabetes. ClinicalTrials.gov lists 8 registered trials linking Metformin Hydrochloride to Type 2 Diabetes: 8 have completed. The most advanced is Phase 4 (NCT00970528). The largest enrolment is 1050 participants (NCT00449930). Registration activity spans 2005 to 2017. The literature layer holds 6 publications for this pair: 1 Cochrane review and 5 clinical trial publications. Publication years run from 2020 to 2025. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Type 2 Diabetes Mellitus ranks 767 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: 1.6-1.7% at 7 years on standard care (population-level cohorts UK and US).
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 64.0 (trials 29.0, literature 15.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 8 completed, 0 other |
| Linked publications | 6 (5 clinical trial publications, 1 Cochrane review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00970528 | Glucose Reduction by Early Acarbose Treatment in Basal Insulin 2009 | completed | Phase 4 | 124 |
| NCT00941161 | Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus 2009 | completed | Phase 4 | 28 |
| NCT00449930 | Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049) 2007 | completed | Phase 3 | 1,050 |
| NCT00915772 | Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid 2009 | completed | Phase 3 | 567 |
| NCT00111631 | A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes 2005 | completed | Phase 2 | 218 |
| NCT03283657 | Diabetes Risk Education and Communication Trial 2017 | completed | Not applicable | 53 |
| NCT03430856 | Comparison of Insulin Tregopil (IN-105) With Insulin Aspart in Type 2 Diabetes Mellitus Patients 2017 | completed | PHASE2, PHASE3 | 143 |
| NCT00818077 | Using Continuous Glucose Monitoring to Understand the Glycemic Impact of Food 2008 | completed | Not applicable | 15 |
Published literature
- Clinical trial publication Fixed dose combination of dapagliflozin, glimepiride and extended-release metformin tablets in patients with type 2 diabetes poorly controlled by metformin and glimepiride: A phase III, open label, randomized clinical study in IndiaSahay R, Gangwani D, Singh M et al. · Diabetes, obesity & metabolism · 2025 · PMID 39950245
- Clinical trial publication Efficacy of Dapagliflozin + Sitagliptin + Metformin Versus Sitagliptin + Metformin in T2DM Inadequately Controlled on Metformin Monotherapy: A Multicentric Randomized TrialSingh AK, Das AK, Murthy LS et al. · Advances in therapy · 2025 · PMID 39636567
- Clinical trial publication Acupotomy combined with metformin hydrochloride tablet for type 2 diabetes mellitus and its effect on serum inflammatory factorsZhu T, Ji L, Gao Z et al. · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2024 · PMID 38467496
- Clinical trial publication Bioequivalence and Safety Assessment of 2 Formulations of Low-Dose Metformin Hydrochloride under Fasting Conditions in Healthy Chinese Participants: A Randomized Phase 1 Clinical TrialSun ML, Xu XW, Liu C et al. · Clinical pharmacology in drug development · 2024 · PMID 38189592
- Clinical trial publication Effect and Safety of Pioglitazone-Metformin Tablets in the Treatment of Newly Diagnosed Type 2 Diabetes Patients with Nonalcoholic Fatty Liver Disease in Shaanxi Province: A Randomized, Double-Blinded, Double-Simulated Multicenter StudyJianfang F, Wanxia X, Xiling G et al. · Journal of diabetes research · 2023 · PMID 37305429
- Cochrane review The feasibility of Chinese massage as an auxiliary way of replacing or reducing drugs in the clinical treatment of adult type 2 diabetes: A systematic review and meta-analysisZhang X, Cao D, Yan M et al. · Medicine · 2020 · PMID 32846852
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Metformin Hydrochloride approved for Type 2 Diabetes?
Metformin Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Type 2 Diabetes would be drug repurposing rather than first-in-human development. This does not mean it is approved for Type 2 Diabetes. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Metformin Hydrochloride in clinical trials for Type 2 Diabetes?
ClinicalTrials.gov lists 8 registered trials linking Metformin Hydrochloride to Type 2 Diabetes: 8 have completed. The most advanced is Phase 4 (NCT00970528). The largest enrolment is 1050 participants (NCT00449930). Registration activity spans 2005 to 2017.
What does the evidence show for Metformin Hydrochloride in Type 2 Diabetes?
Metformin Hydrochloride has both completed registered trials and synthesis-level publications linked to Type 2 Diabetes. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.