Data updated: May 26, 2026
PRECOSE (acarbose)
Trial Activity: Mature
Metabolic
Approved 1995-09-06
Development Insights
Sanofi conducting 3 trials (11%)
18 indications explored (Broad Platform)
→ type 2 diabetes mellitus (11 trials)
→ diabetes mellitus, type 2 (5 trials)
→ aging (2 trials)
3
Indications
--
Phase 3 Trials
30
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1995-09-06
- Routes
- ORAL
- Dosage Forms
- TABLET
PRECOSE Approval History
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
54 FDA actions from 1995 to 2015 · 2 indication expansions
Nov 2014 SUPPL
Mfg · Manufacturing (CMC)
Jun 2000 SUPPL
Mfg
Feb 1998 SUPPL
Label
Nov 1997 SUPPL
Mfg
Oct 1997 SUPPL
Mfg
May 1997 SUPPL
Mfg
Dec 1996 SUPPL
Label
Jan 1996 SUPPL
Label
Sep 1995 ORIGINAL
New Drug
What PRECOSE Treats
3 FDA approvalsOriginally approved for its first indication in 1995 . Covers 3 distinct patient populations.
- Other (3)
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Clinical Trial Registry
26 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02953093 SAIL results posted | 2016-6933 | Ph 2 | terminated | Study of Acarbose in Longevity |
| NCT01514838 | 1941-CL-2003 | Ph 3 | terminated | A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus |
| NCT03380546 ACARB-GDM | P150942 | Ph 3 | terminated | Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus. |
| NCT02589353 | IRB # 5373 | Ph 4 | completed | Human Oral Detection of Glucose Olygomers |
| NCT03794336 ACADEMIC | ALOGLC08867 U1111-1210-0679 | Ph 4 | completed | Efficacy and Safety of Alogliptin vs. Acarbose in Chinese Type 2 Diabetes Mellitus (T2DM) Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive |
| NCT03359837 SWITCH | LANTUL07194 U1111-1186-3400 | Ph 4 | completed | Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy |
| NCT02836704 | LANTUL07191 U1111-1172-2903 | Ph 4 | completed | Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) |
| NCT03344341 | D1690C00060 | Ph 4 | terminated | A Phase IV Study in Drug-Naive Patients With T2DM in China |
| NCT01914133 PPH | H13-01316 G-13-0001812 | Ph 2 | completed | Acarbose and Older Adults With Postprandial Hypotension |
| NCT02685852 | 1503M65841 | Ph 1 | completed | Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia |
| NCT01490918 results posted | ACADEMIC | Ph 4 | completed | Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients |
| NCT03349684 | 17886 | Ph 3 | completed | Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients |
| NCT01181674 results posted | REMIT Pilot Control # 139433, 143584, 10-346 | Ph 4 | completed | Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT Pilot Trial) |
| NCT02072096 IMPERIUM results posted | 14842 F3Z-MC-IOQL, 2013-001473-24 | Ph 4 | terminated | A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM) |
| NCT02865499 results posted | HSC20120304 | Ph 2 | completed | Acarbose Anti-aging Effects in Geriatric Subjects (Substudy B & C) |
| NCT02049814 results posted | BASCN1201 U1111-1147-3393, VOG-P4-001 | Ph 4 | completed | Efficacy and Safety of Voglibose Compared With Acarbose in Participants With Type 2 Diabetes |
| NCT01709305 results posted | 0431-313 | Ph 4 | completed | A Study of the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose When Added to Sitagliptin + Metformin Combination Therapy in Chinese Participants With Diabetes (MK-0431-313) |
| NCT01177384 results posted | 0431-130 2010_543, CTRI/2011/10/002072 | Ph 3 | completed | Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130) |
| NCT02315495 | ISSSAXA0015 | Ph 3 | completed | Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes |
| NCT00829660 ACE | 11232 ISRCTN91899513 | Ph 4 | completed | Acarbose Cardiovascular Evaluation Trial |
| NCT02243176 SMART results posted | D1680L00018 | Ph 4 | completed | 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy |
| NCT02143765 Match-101 | ZhongdaH-Match | Ph 4 | completed | Efficacy and Safety of Mitiglinide vs Acarbose in Patients With Type 2 Diabetes Mellitus |
| NCT01839344 | 13A-1334 | Ph 2 | completed | Effects of Quercetin on Blood Sugar and Blood Vessel Function in Type 2 Diabetes. |
| NCT02355509 | REF.1467 | Ph 4 | completed | Effect of Acarbose on Postprandial Lipoprotein Levels in Glucose Intolerant Patients |
| NCT02211950 | 1224.22 | Ph 1 | completed | Relative Bioavailability of BI 44847 in Different Ethnic Groups and Evaluation of Effect of Diet and Acarbose Coadministration on Bioavailability Following Oral Administration of 200 mg BI 44847 in Healthy Male Volunteers |
| NCT01030952 results posted | CDJN608ACN07 | Ph 4 | completed | Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PRECOSE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment