Type 2 Diabetes MellitusPhase 4NCT00778622

Body Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients

A Phase 4 study testing Metformin XR in people with Type 2 Diabetes Mellitus, run by Bristol-Myers Squibb at 14 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the effect of the baseline body mass index (BMI) on the response to Glucophage XR monotherapy in glycemic control in Chinese patients with newly diagnosed type 2 diabetes Read more about this study

Who is it for?: Ages 17 to 79 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Metformin XR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 371 participants
Where: 14 sitesChina
Study dates: Nov 2009to Mar 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 17 to 79 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Signed Written Informed Consent
Age≥ 17 and <80 years,
Newly diagnosed T2DM (defined as T2DM diagnosed within 6 months prior to enrollment)
Oral antidiabetic agents naïve (defined as without receiving any anti-diabetic medication therapy before, or having received anti-diabetic medication ≤ 14 days but not received any antidiabetic medication within the last 1 month prior to enrollment)
HbA1c ≥ 7.0% and ≤10.0%

Who cannot join

Women of child bearing potential
body mass index (BMI)≥35 Kg/m2 or BMI <18.5 Kg/m2
Hemoglobin A1c (HbA1c)>10.0% or <7.0%
Active liver disease and/or significant abnormal liver function
Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
Congestive heart failure defined as New York Heart Association (NYHA) class III or IV and /or left ventricular ejection fraction ≤40%

Show all 20Show fewer

Significant cardiovascular history with the past 6 months
Severe retinopathy, persistent uncontrolled hypertension (SBP≥180mmHg, or DBP≥105mmHg)
Severe chronic gastrointestinal disease
History of alcohol abuse or illegal drug abuse within the past 12 months
Diagnosed anemia
Creatine kinase ≥3 X ULN
Serum creatinine ≥1.5 mg/dL(133μmol/L) [males], ≥1.4 mg/dL(124 μmol/L)[females]
Alanine amino transferase (ALT) and/or aspartate amino transferase (AST)> 1.5 X ULN and/or total bilirubin > 2 X ULN
Hemoglobin <12g/dL [males], <11g/dL [females]
Allergies and Adverse Drug Reactions
Prohibited Treatments and/or Therapies
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Subjects decline to participate

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

China14 sites

Local Institution
Beijing, Beijing Municipality, 100028
Local Institution
Beijing, Beijing Municipality, 100034
Local Institution
Beijing, Beijing Municipality, 100044
Local Institution
Beijing, Beijing Municipality, 100088
Local Institution
Beijing, Beijing Municipality, 100730
Local Institution
Beijing, Beijing Municipality, 101100
Local Institution
Beijing, Beijing Municipality, 200016
Local Institution
Guangdong, Guangdong, 510180
Local Institution
Guangdong Province, Guangdong, 510180
Local Institution
Guangdong Province, Guangdong, 528000
Local Institution
Shanghai, Shanghai Municipality, 200003
Local Institution
Shanghai, Shanghai Municipality, 200092
Local Institution
Shanghai, Shanghai Municipality, 201100
Local Institution
Shanghai, Shanghai Municipality, 201200

Other trials in China

About this study

Official title: The Relationship Between Baseline Body Weight and Glycemic Control Following Metformin Extended-Release Tablets (Glucophage XR) Monotherapy in Chinese Patients With Newly Diagnosed Type 2 Diabetes

Conditions: Type 2 Diabetes Mellitus
Being tested: Metformin XR
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.

Metformin XRDrug
Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks

Study groups in NCT00778622
Study group	Role	What they receive
A1	Experimental	Normal Weight by Body Weight Index Receives: Drug: Metformin XR
A2	Experimental	Overweight by Body Weight Index Receives: Drug: Metformin XR
A3	Experimental	Obese by Body Weight Index Receives: Drug: Metformin XR

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS)
Baseline for HbA1c is defined as that value obtained at screening visit. HbA1c was measured as a percent (%) of hemoglobin; normal range was 4.7 to 6.4% and values were obtained through a central laboratory. The Last Observation Carried Forward (LOCF) data set includes data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit.
Measured: Baseline to Week 16

Secondary outcomes (8)

Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set
Baseline was defined as the value obtained at the screening visit. FPG was measured in millimoles/Liter (mmol/L) and obtained through local laboratories.
Measured: Baseline to Week 16
Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set
For fasting total cholesterol (TC), baseline is defined as Day 1 (first day of treatment). Total cholesterol was measured in millimoles per liter (mmol/L) and obtained through local laboratories.
Measured: Baseline to Week 16
Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set
Baseline was defined as values obtained on Day 1. Low-density lipoprotein cholesterol (LDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories.
Measured: Baseline to Week 16
Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set
Baseline was defined as value obtained on Day 1 (first day of treatment). High-density lipoprotein cholesterol (HDL-C) was measured in millimoles per liter (mmol/L) and obtained through local laboratories.
Measured: Baseline to Week 16
Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set
Baseline was defined as value obtained on Day 1 (first day of treatment). Triglycerides (TG) were measured in millimoles per liter (mmol/L)and values obtained through local laboratories.
Measured: Baseline to Week 16
Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set
Baseline was defined as value obtained on Day 1 (first day of treatment). C-Reactive Protein (CRP) was measured in milligrams/liter (mg/L) and values were obtained through a central laboratory; normal was less than 5.0 mg/L.
Measured: Baseline to Week 16
Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set
Baseline was defined as value obtained on Day 1 (first day of treatment). PAI-1 (activity) was measured in units/milliliter (U/mL)and values obtained through a central laboratory; normal was less than 25.00 U/mL.
Measured: Baseline to Week 16
Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set
Baseline was defined as value obtained on Day 1 (first day of treatment). Adiponectin was measured in milligrams/liter (mg/L) and values obtained through a central laboratory; normal range was 1.20 to 20.00 mg/L.
Measured: Baseline to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Mar 2011

First posted23 Oct 2008 (estimated)
Study startNov 2009
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe 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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 371 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00778622
Sponsor's protocol ID: CV138-097
Status last verified: Aug 2013
First submitted: 22 Oct 2008
Last updated: 23 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ji L, Li H, Guo X, Li Y, Hu R, Zhu Z. Impact of baseline BMI on glycemic control and weight change with metformin monotherapy in Chinese type 2 diabetes patients: phase IV open-label trial. PLoS One. 2013;8(2):e57222. doi: 10.1371/journal.pone.0057222. Epub 2013 Feb 28.
PubMed 23468941

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Relationship Between Baseline Body Weight and Glycemic Control Following Metformin Extended-Release Tablets (Glucophage XR) Monotherapy in Chinese Patients With Newly Diagnosed Type 2 Diabetes
ClinicalTrials.gov ID: NCT00778622
Acronym / sponsor ID: CV138-097
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 371 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 23 Oct 2008 (estimated)
Results: Posted 20 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
A1	Experimental	Drug: Metformin XRNormal Weight by Body Weight Index
A2	Experimental	Drug: Metformin XROverweight by Body Weight Index
A3	Experimental	Drug: Metformin XRObese by Body Weight Index

Who may qualify

Ages: 17 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Signed Written Informed Consent
Age≥ 17 and <80 years,
Newly diagnosed T2DM (defined as T2DM diagnosed within 6 months prior to enrollment)
Oral antidiabetic agents naïve (defined as without receiving any anti-diabetic medication therapy before, or having received anti-diabetic medication ≤ 14 days but not received any antidiabetic medication within the last 1 month prior to enrollment)
HbA1c ≥ 7.0% and ≤10.0%

Key exclusion criteria (20 listed)

Women of child bearing potential
body mass index (BMI)≥35 Kg/m2 or BMI <18.5 Kg/m2
Hemoglobin A1c (HbA1c)>10.0% or <7.0%
Active liver disease and/or significant abnormal liver function
Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma

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
Metformin XRTablets, Oral, 500mg tid, 1500 mg/day, 16 weeks	Drug	A1, A2, A3

Primary outcome

Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS)
Time frame: Baseline to Week 16
Baseline for HbA1c is defined as that value obtained at screening visit. HbA1c was measured as a percent (%) of hemoglobin; normal range was 4.7 to 6.4% and values were obtained through a central laboratory. The Last Observation Carried Forward (LOCF) data set includes data recorded at a given visit or, if no observation is recorded at that visit, data carried forward from the previous visit.

8 secondary outcomes

Mean Change From Baseline at Week 16 (95% Confidence Interval) of Fasting Plasma Glucose (FPG) - Full Analysis Set
Time frame: Baseline to Week 16
Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Total Cholesterol (TC) - Full Analysis Set
Time frame: Baseline to Week 16
Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Low-density Lipoprotein Cholesterol (LDL-C) - Full Analysis Set
Time frame: Baseline to Week 16
Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting High-density Lipoprotein Cholesterol (HDL-C) - Full Analysis Set
Time frame: Baseline to Week 16
Mean Change From Baseline at Week 16 (95% Confidence Interval) in Fasting Triglycerides (TG) - Full Analysis Set
Time frame: Baseline to Week 16
Mean Change From Baseline at Week 16 (95% Confidence Interval) in C-Reactive Protein (CRP) - Full Analysis Set
Time frame: Baseline to Week 16
Mean Change From Baseline at Week 16 (95% Confidence Interval) in Plasminogen Activator Inhibitor-1 (PAI-1) - Full Analysis Set
Time frame: Baseline to Week 16
Mean Change From Baseline at Week 16 (95% Confidence Interval) in Adiponectin - Full Analysis Set
Time frame: Baseline to Week 16

Results and safety

Results posted to the registry on 20 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glucophage XR in Normal Weight Participants	125	109
Glucophage XR in Overweight Participants	122	107
Glucophage XR in Obese Participants	124	109

Primary outcome: Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS)

Time frame: Baseline to Week 16. Mean (95% Confidence Interval). Unit: percentage of hemoglobin

Measure	Glucophage XR in Normal Weight Participants n = 111	Glucophage XR in Overweight Participants n = 111	Glucophage XR in Obese Participants n = 112
Value	-1.95 (0.922)	-1.79 (0.941)	-1.68 (0.854)

Glucophage XR in Normal Weight Participants vs Glucophage XR in Overweight Participants vs Glucophage XR in Obese Participants: p = 0.0806, ANCOVA
Glucophage XR in Normal Weight Participants vs Glucophage XR in Overweight Participants: p = 0.1984, t-test, 2 sided
Glucophage XR in Normal Weight Participants vs Glucophage XR in Obese Participants: p = 0.0232, t-test, 2 sided

Population analysed: Full Analysis Set included participants who were enrolled, took at least 1 study medication and had at least 1 post baseline HbA1c assessment. Baseline data was not carried forward or averaged with on-treatment data to impute missing values for the LOCF data set.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 16 Weeks. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glucophage XR in Normal Weight Participants	1 of 125 (0.8%)	43 of 125 (34.4%)	Not reported
Glucophage XR in Overweight Participants	0 of 122 (0%)	47 of 122 (38.5%)	Not reported
Glucophage XR in Obese Participants	1 of 124 (0.8%)	46 of 124 (37.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23468941Ji L, Li H, Guo X, Li Y, Hu R, Zhu Z. Impact of baseline BMI on glycemic control and weight change with metformin monotherapy in Chinese type 2 diabetes patients: phase IV open-label trial. PLoS One. 2013;8(2):e57222. doi: 10.1371/journal.pone.0057222. Epub 2013 Feb 28.

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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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin XR in people with Type 2 Diabetes Mellitus, run by Bristol-Myers Squibb at 14 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 5 inclusion and 20 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 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 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?

Yes. Results are posted in the registry (first posted 20 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change From Baseline at Week 16 (95% Confidence Interval) in Glycosated Hemoglobin A1c (HbA1c) (Last Observation Carried Forward) - Full Analysis Set (FAS) (time frame: Baseline to Week 16). 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 NCT00778622, 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 23 Aug 2013.