Diabetes Mellitus, Type 2Phase 3NCT03349684
Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients
A Phase 3 study testing Acarbose and Metformin in people with Diabetes Mellitus, Type 2, run by Bayer at 29 sites in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Acarbose and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 287 participants
- Where
- 29 sitesChina
- Study dates
- 5 Mar 2018to 21 Aug 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, aged 18 to less than 80 years
- Diabetes mellitus type 2, that is insufficently controlled with metformin defined by HbA1c between 7.0 % and 10.0%, inclusive
- Body mass index between 22 and 45 kg/m^2, inclusive
- Women and men of reproductive potential must agree to use adequate contraception when sexually active
Who cannot join
- Fasting plasma glucose > 14.0 mmol/L
- Severe metabolic diabetic complications
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
China29 sites
Emergency General Hospital
Beijing, 100028
Peking Union Medical College Hospital CAMS
Beijing, 100730
Beijing Pinggu Hospital
Beijing, 101200
Jilin Province People's Hospital
Changchun, Jilin, 130021
Changsha Central Hospital
Changsha, 410004
1st Peopl's Hosp of Changzhou 3rd Affil Hosp of Soochow Univ
Changzhou, Jiangsu, 213003
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Chenzhou No. 1 People's Hospital
Chenzhou, Hunan, 423000
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
Guangzhou, Guangdong, 510120
The 3rd Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510150
The Second Affliated Hospital of Hainan Medical University
Haikou, Hainan, 570311
Anhui Provincial Hospital
Hefei, Anhui, 230001
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Huai'an First People's Hospital, Nanjing Medical University
Huai'an, Jiangsu, 223300
Shandong Provincial Hospital
Jinan, Shandong, 250021
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272000
1st Affiliated Hospital of Henan Science and Technology Univ
Luoyang, Henan, 471000
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Jiangxi PingXiang people's Hospital
Pingxiang, 337055
Hainan Third People's Hospital (Province Nongken Sanya Hopt)
Sanya, Hainan, 572000
Shanghai Tenth People's Hospital
Shanghai, 200072
Taihe Hospital
Shiyan, Hubei, 442008
Tianjin Union Medicine Centre (People's Hospital of Tianjin)
Tianjin, 300121
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
Wuhan, Hubei, 430030
1st Affiliated Hospital of Xi'an Jiaotong Medical University
Xi'an, Shaanxi, 710061
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
The first affiliated hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: A Multicenter, Randomized, Double-Blinded, Monotherapy-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of the Acarbose and Metformin in Loose-Dose Combination Compared to Metformin Monotherapy in Subjects WithType 2 Diabetic Mellitus (T2DM) That is Inadequately Controlled by Metformin Monotherapy
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
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Acarbose, Metformin, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcarboseDrug
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
MetforminDrug
500 mg 3 times daily, oral, with the first mouthful of main meal
PlaceboDrug
Acarbose matching placebo, oral
| Study group | Role | What they receive |
|---|---|---|
| Acarbose plus metformin arm | Experimental | Participants received loose combination of acarbose and metformin 3 times daily. Receives: Drug: Acarbose; Drug: Metformin; Drug: Placebo |
| Metformin plus placebo arm | Active comparator | Participants received loose combination of placebo and metformin 3 times daily. Receives: Drug: Metformin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in the levels of glycosylated hemoglobin (HbA1c)
Measured: At baseline and at treatment week 16
Secondary outcomes (6)
Responder rates
Defined as the percentage of subjects who achieve optimal glycemic control, defined by hemoglobin A1c of 1) < 7%, and 2) < 6.5%
Measured: At week 16
Change in 2-hour postprandial plasma glucose (PPG)
Measured: At baseline and at treatment week 16
Change in fasting plasma glucose (FPG) levels
Measured: At baseline and at treatment week 16
Change in fasting serum insulin levels
Measured: 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.
Measured: At baseline and at treatment week 16
Number of participants with adverse events
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start5 Mar 2018
- Primary completion12 Aug 2019
- Study completion21 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349684
- Sponsor's protocol ID
- 17886
- Status last verified
- Aug 2020
- First submitted
- 17 Nov 2017
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blinded, Monotherapy-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of the Acarbose and Metformin in Loose-Dose Combination Compared to Metformin Monotherapy in Subjects WithType 2 Diabetic Mellitus (T2DM) That is Inadequately Controlled by Metformin Monotherapy
- ClinicalTrials.gov ID
- NCT03349684
- Acronym / sponsor ID
- 17886
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 21 Aug 2019 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acarbose plus metformin arm | Experimental | Drug: Acarbose, Drug: Metformin, Drug: PlaceboParticipants received loose combination of acarbose and metformin 3 times daily. |
| Metformin plus placebo arm | Active comparator | Drug: Metformin, Drug: PlaceboParticipants received loose combination of placebo and metformin 3 times daily. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females, aged 18 to less than 80 years
- Diabetes mellitus type 2, that is insufficently controlled with metformin defined by HbA1c between 7.0 % and 10.0%, inclusive
- Body mass index between 22 and 45 kg/m^2, inclusive
- Women and men of reproductive potential must agree to use adequate contraception when sexually active
Key exclusion criteria (2 listed)
- Fasting plasma glucose > 14.0 mmol/L
- Severe metabolic diabetic complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcarboseUptitrated 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 | Drug | Acarbose plus metformin arm |
| Metformin500 mg 3 times daily, oral, with the first mouthful of main meal | Drug | Acarbose plus metformin arm, Metformin plus placebo arm |
| PlaceboAcarbose matching placebo, oral | Drug | Acarbose plus metformin arm, Metformin plus placebo arm |
Primary outcome
Absolute change in the levels of glycosylated hemoglobin (HbA1c)
Time frame: At baseline and at treatment week 16
6 secondary outcomes
Responder rates
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
Time frame: At baseline and at treatment week 16
Number of participants with adverse events
Time frame: Up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acarbose and Metformin in people with Diabetes Mellitus, Type 2, run by Bayer at 29 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in the levels of glycosylated hemoglobin (HbA1c) (time frame: At baseline and at treatment week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.