A Phase 3 interventional study of Acarbose and Metformin in Diabetes Mellitus, Type 2, sponsored by Bayer. Completed at 29 sites in China. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2020-08-05.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
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Among 30 studies testing acarbose in Diabetes Mellitus, Type 2 — none open to participants now, none under way, none of them phase 3. Acarbose · Diabetes Mellitus, Type 2.
Among the 30 studies testing acarbose in Diabetes Mellitus, Type 2, this one is the 5th largest by enrollment of the 29 interventional ones that give a count, is one of 2 that started in 2018, is one of 8 in phase 3, and was the 24th registered.
10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →None of the 30 studies testing acarbose in Diabetes Mellitus, Type 2 is open now. The open studies under Diabetes Mellitus, Type 2, anywhere →
Acarbose: first FDA approval 1995 (PRECOSE). What it is approved for, and how studies give it, is on its page →
Of the 882 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years to 79 Years · all sexes · no healthy volunteers.
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30 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 287 is above the median of 80 across 8,356 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 100 across the 29 interventional studies. Of the 22 that completed or were terminated, 3 (14%) have results posted.
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10 of 30 have an industry lead sponsor. The 10 most frequent:
Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
37 studies in Diabetes Mellitus, Type 2 by Bayer: 3 open now, 6 under way, none of them phase 3. Of 29 finished, 4 (14%) have results posted.
Among the 37 studies in Diabetes Mellitus, Type 2 by Bayer, this one is the 5th largest by enrollment of the 12 interventional ones that give a count, is one of 3 that started in 2018, is one of 3 in phase 3, and was the 13th registered.
Bayer’s Diabetes Mellitus, Type 2 studies by the year they started, since 2008.
None of the studies under way reaches primary completion within a year.
Among the 30 studies testing acarbose in Diabetes Mellitus, Type 2, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Bayer’s 37 in Diabetes Mellitus, Type 2:
This tab as a report to print or save as PDF → With an account.
To demonstrate the efficacy and safety of acarbose and metformin loose-dose combination as compared to metformin monotherapy in the treatment of subjects with T2DM that is inadequately controlled by metformin alone
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received loose combination of acarbose and metformin 3 times daily.
Drug: Acarbose · Drug: Metformin · Drug: Placebo
Participants received loose combination of placebo and metformin 3 times daily.
Drug: Metformin · Drug: Placebo
Uptitrated in the treatment phase from 50 mg per day for 1 week, followed by 100 mg per day for another week, and 150 mg per day for the rest 14 weeks, oral, with the first mouthful of main meal
500 mg 3 times daily, oral, with the first mouthful of main meal
Acarbose matching placebo, oral
Absolute change in the levels of glycosylated hemoglobin (HbA1c)
Time frame: At baseline and at treatment week 16
Responder rates
Defined as the percentage of subjects who achieve optimal glycemic control, defined by hemoglobin A1c of 1) \< 7%, and 2) \< 6.5%
Time frame: At week 16
Change in 2-hour postprandial plasma glucose (PPG)
Time frame: At baseline and at treatment week 16
Change in fasting plasma glucose (FPG) levels
Time frame: At baseline and at treatment week 16
Change in fasting serum insulin levels
Time frame: At baseline and at treatment week 16
Change in insulin resistance score
Insulin resistance score was calculated based on the homeostasis model assessment (HOMA) model: fasting plasma glucose in mmol/l \* fasting serum insulin in mU/L / 22.5.
Time frame: At baseline and at treatment week 16
Number of participants with adverse events
Time frame: Up to 16 weeks
Ran from Mar 2018 to primary completion in Aug 2019, 17 months.
Of 438 industry-sponsored phase 3 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 26. This study's 17 months is below that.
Counting every sponsor, half of 525 studies reached it within 20 months; a quarter within 14 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acarbose