Type 2 DiabetesPhase 4CGMSNCT02438397
the Efficacy of Acarbose and Metformin on Blood Glucose Fluctuation When Combined With Premix Insulin
A Phase 4 study testing premix insulin, metformin and Acarbose in people with Type 2 Diabetes, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
the study objective: to explore the efficacy of acarbose and metformin on glucose fluctuations as add on therapy in type 2 diabetes patients inadequately controlled with premix insulin. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- premix insulin, metformin and Acarbose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Oct 2016
- Phase
- Phase 4
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed T2DM patients (WHO, 1999).
- Premix Insulin therapy for more than 3 months, the daily dosage of insulin >20IU and <1IU/kg
- 30 ≤Age ≤ 70 years old, male or female
- 7.0 ≤ HbA1c ≤10.0%
- 18.5≤ BMI ≤ 35 kg/m2
- Written Informed consent
Who cannot join
- Subject with type 1 diabetes or gestational diabetes mellitus and other specific types DM
- Those who can not tolerate AGI or who is suffering GI disease
- Metformin contradiction
- Concomitant 2 oral anti-diabetes medicine, or 1 OAD with maximum dose
- Subject with repeated severe hypoglycemia and/or unawareness of hypoglycemia
- Known or suspected allergy to trial product(s) or related products
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- Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods throughout the trial
- Impaired liver function,
- Any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, cancer, TB, acute infection
- Uncontrolled hypertension
- Concomitant treatment which influences blood glucose
- Impaired renal function
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the 6th affliliated hospital of Shanghai Jiaotong university
Shanghai, Shanghai Municipality, 200233
About this study
Official title: Explore the Efficacy of Acarbose and Metformin on Blood Glucose Fluctuation When Combined With Premix Insulin in Chinese Type 2 Diabetes by CGMS
the study objective: to explore the efficacy of acarbose and metformin on glucose fluctuations as add on therapy in type 2 diabetes patients inadequately controlled with premix insulin.
Read the detailed description
Study Design:Prospective, parallel group, active-control, randomized, open-label.
Study Organization:Single-center in China. Endocrinology and metabolism department of 6th affiliated hospital of Shanghai Jiaotong university Study Population: Type 2 diabetes inadequately controlled by premix-insulin therapy,40 patients per arm(acarbose add on/ metformin add on) both acarbose and metformin are widely used with premix-insulin in clinical practice, for the better glucose control and lower hypoglycemia incident.
Acarbose delay the absorption of digested carbohydrates from the small intestine and thus lower both postprandial glucose and insulin levels which sequently improve glucose fluctuation Metformin improve the insulin resistance reduce the gluconeogenesis, glucose output and thus lower the fasting glucose
- Conditions
- Type 2 Diabetes
- Being tested
- premix insulin, metformin, Acarbose
- 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.
premix insulinDrug
Also called human insulin or analog
Premix-insulin(human insulin or analog) treatment will continue
metforminDrug
Also called glucophage
500 mg tid by Merck
AcarboseDrug
Also called Glucobay
100mg tid by Bayer
| Study group | Role | What they receive |
|---|---|---|
| metformin+premix insulin | Active comparator | metformin:500mg tid Receives: Drug: premix insulin; Drug: metformin |
| acarbose+premix insulin | Experimental | acarbose:100mg tid Receives: Drug: premix insulin; Drug: Acarbose |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAGE: mean amplitude of glycemic excursion/MODD: mean of daily differences
Measured: 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startDec 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiping Jia, Shanghai 6th People's Hospital
- Investigators
- Weiping Jia, doctor, Principal investigator, the 6th affiliated hospital of Shanghai Jiaotong university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438397
- Sponsor's protocol ID
- BHC-17782
- Acronym
- CGMS
- Status last verified
- May 2015
- First submitted
- 5 May 2015
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gao F, Li C, Wang Y, Lu J, Lu W, Zhou J, Yin J, Ma X. Growth differentiation factor 15 is not associated with glycemic control in patients with type 2 diabetes mellitus treated with metformin: a post-hoc analysis of AIM study. BMC Endocr Disord. 2022 Oct 22;22(1):256. doi: 10.1186/s12902-022-01176-3.
PubMed 36273168
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Efficacy of Acarbose and Metformin on Blood Glucose Fluctuation When Combined With Premix Insulin in Chinese Type 2 Diabetes by CGMS
- ClinicalTrials.gov ID
- NCT02438397
- Acronym / sponsor ID
- CGMS / BHC-17782
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 8 May 2015 (estimated)
- 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.
the study objective: to explore the efficacy of acarbose and metformin on glucose fluctuations as add on therapy in type 2 diabetes patients inadequately controlled with premix insulin.
Detailed description
Study Design:Prospective, parallel group, active-control, randomized, open-label.
Study Organization:Single-center in China. Endocrinology and metabolism department of 6th affiliated hospital of Shanghai Jiaotong university Study Population: Type 2 diabetes inadequately controlled by premix-insulin therapy,40 patients per arm(acarbose add on/ metformin add on) both acarbose and metformin are widely used with premix-insulin in clinical practice, for the better glucose control and lower hypoglycemia incident.
Acarbose delay the absorption of digested carbohydrates from the small intestine and thus lower both postprandial glucose and insulin levels which sequently improve glucose fluctuation Metformin improve the insulin resistance reduce the gluconeogenesis, glucose output and thus lower the fasting glucose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin+premix insulin | Active comparator | Drug: premix insulin, Drug: metforminmetformin:500mg tid |
| acarbose+premix insulin | Experimental | Drug: premix insulin, Drug: Acarboseacarbose:100mg tid |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed T2DM patients (WHO, 1999).
- Premix Insulin therapy for more than 3 months, the daily dosage of insulin >20IU and <1IU/kg
- 30 ≤Age ≤ 70 years old, male or female
- 7.0 ≤ HbA1c ≤10.0%
- 18.5≤ BMI ≤ 35 kg/m2
Key exclusion criteria (12 listed)
- Subject with type 1 diabetes or gestational diabetes mellitus and other specific types DM
- Those who can not tolerate AGI or who is suffering GI disease
- Metformin contradiction
- Concomitant 2 oral anti-diabetes medicine, or 1 OAD with maximum dose
- Subject with repeated severe hypoglycemia and/or unawareness of hypoglycemia
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 |
|---|---|---|
| premix insulinAlso: human insulin or analogPremix-insulin(human insulin or analog) treatment will continue | Drug | acarbose+premix insulin, metformin+premix insulin |
| metforminAlso: glucophage500 mg tid by Merck | Drug | metformin+premix insulin |
| AcarboseAlso: Glucobay100mg tid by Bayer | Drug | acarbose+premix insulin |
Primary outcome
MAGE: mean amplitude of glycemic excursion/MODD: mean of daily differences
Time frame: 12 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
- Derived from this study: PubMed 36273168Gao F, Li C, Wang Y, Lu J, Lu W, Zhou J, Yin J, Ma X. Growth differentiation factor 15 is not associated with glycemic control in patients with type 2 diabetes mellitus treated with metformin: a post-hoc analysis of AIM study. BMC Endocr Disord. 2022 Oct 22;22(1):256. doi: 10.1186/s12902-022-01176-3.
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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.
Weiping Jia, doctor principal investigator
the 6th affiliated hospital of Shanghai Jiaotong university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing premix insulin, metformin and Acarbose in people with Type 2 Diabetes, run by Shanghai 6th People's Hospital at 1 site 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jian Zhou, doctor (18930172033, zhoujian8337@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAGE: mean amplitude of glycemic excursion/MODD: mean of daily differences (time frame: 12 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02438397, which also lists 1 linked publication.
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 8 May 2015.