Diabetes MellitusPhase 2PioglitazoneNCT01935804
Effect of Pioglitazone Versus Metformin on Bone Health in Postmenopausal Women With Type 2 Diabetes
A Phase 2 study testing Pioglitazone and Metformin in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The study tests whether pioglitazone (PIO)as compared to metformin (MET)affects bone health including bone mineral density, bone turnover markers, and osteocyte biomarker in patients with type 2 diabetes (T2DM). Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
- What is being tested?
- Pioglitazone and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2009to Jan 2014
- Phase
- Phase 2
- 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 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMD T-score greater than -2.5 at the total hip, femoral neck, and lumbar spine;
- No prior antidiabetic therapy;
- Drug-naïve with glycosylated hemoglobin A1c (HbA1c) ≥ 7.0 to ≤ 10.0%. 53.2 mmol/mol to 88.2 mmol/mol);
- Body-mass index of 40 Kg/m2 and less;
- Stable body weight for at least 4 months.
Who cannot join
- Type 1 diabetes mellitus (presence of GAD auto antibodies);
- History of diabetes or uncontrolled hypertension;
- Treatment with antidiabetic agents including TZDs;
- Chronic diseases known to affect bone;
- Previous treatment with estrogens and other medications known to affect bone ;
- Creatinine clearance less than 60 ml/min
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Center of Excellence for Osteoporosis Research, King Abdulaziz University
Jeddah, Mecca Region, 21589
About this study
Official title: Phase 1 Study of Pioglitazone Versus Metformin on Bone Health in Postmenopausal Women With Type 2 Diabetes
The study tests whether pioglitazone (PIO)as compared to metformin (MET)affects bone health including bone mineral density, bone turnover markers, and osteocyte biomarker in patients with type 2 diabetes (T2DM).
Read the detailed description
Women with T2DM exhibit normal or higher bone mineral density (BMD) for their age, but with approximately twice the overall risk of bone fragility compared with nondiabetic subjects. Known the apparent association between T2DM and the risk of bone fragility, examining the effects of commonly used oral antidiabetic agents; such as MET and thiazolidinediones (TZDs; for example rosiglitazone [ROS] or PIO), on BMD and/or bone turnover is of great clinical relevance for both diabetic patients and their treating physicians. Recent clinical trials, showed that women treated with ROS had higher risk of bone fragility and self-reported adverse events. Similarly, women on long-term treatment with PIO for T2DM experienced higher incidence of distal extremity fractures. TZDs are agonists of the nuclear transcription factor peroxisome proliferator- activated receptor-γ (PPAR-γ) which increase insulin sensitivity and improve glycemic control in T2DM. PPAR (γ) acts also as a molecular factor that favours adipogenesis over osteoblastogenesis of mesenchymal stem cells. The latter was suggested as a potential mechanism for the effects of TZDs on bone among others. In humans, TZDs decrease BMD and increase bone fragility risk. This study tests whether pioglitazone as compared to MET (both are commonly used in the treatment of T2DM in Saudi Arabia and other countries) affects bone health including bone mineral density, bone turnover markers, and osteocyte biomarker in patients with T2DM.
- Being tested
- Pioglitazone, Metformin
- Keywords
- pioglitazone, metformin, hyperglycemic agents, physiological effects of drugs, bone health
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Actos
30 mg/daily for 12 months
MetforminDrug
Also called Glucophage
850 mg/daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 1 | Experimental | Pioglitazone given 30mg/once daily for 12 months. Receives: Drug: Pioglitazone |
| Active comparator: 2 | Active comparator | Metformin given 850 mg/twice daily for 12 months. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean percentage change in BMD at various sites by Dual energy X-ray absorptiometry(DXA) from baseline and at 6, 12 months in PIO versus MET treatment group.
The primary endpoint was change in mean percentage change in BMD values at the lumbar spine (L1-L4), femoral neck and total hip by DXA from baseline and at 6 and 12 months in the PIO and the MET treatment groups.
Measured: 6-18 months
Secondary outcomes (1)
Bone turnover Markers and other Biomarkers
Secondary end-points were changes in serum sclerostin, serum bone-specific alkaline phosphatase (BSAP), serum procollagen type1 N-terminal propeptide (P1NP) and serum C-terminal crosslinking telopeptide of type 1 collagen (CTX); and urinary N-terminal crosslinking telopeptide type 1 collagen (u-NTX); serum calcium, 25-hydroxyvitamin D (25-OHD), and serum Dickkopf-1( DKK-1) at various time intervals from baseline between PIO vs MET treatment.
Measured: 6-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startJan 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed-Salleh M. Ardawi, King Abdulaziz University
- Investigators
- Mohammed-Salleh M Ardawi, PhD, FRCPath, Principal investigator, Center of Excellence for Osteoporosis Research and Faculty of Medicine, King Abdulaziz UniversityAbdulrahim A Rouzi, FRCPC, Study director, Center of Excellence for Osteoporosis Research, and Faculty of Medicine, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935804
- Sponsor's protocol ID
- CEOR-01-08
- Acronym
- Pioglitazone
- Status last verified
- Jun 2014
- First submitted
- 27 Aug 2013
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Pioglitazone Versus Metformin on Bone Health in Postmenopausal Women With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01935804
- Acronym / sponsor ID
- Pioglitazone / CEOR-01-08
- Keywords
- pioglitazone, metformin, hyperglycemic agents, physiological effects of drugs, bone health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 5 Sep 2013 (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 tests whether pioglitazone (PIO)as compared to metformin (MET)affects bone health including bone mineral density, bone turnover markers, and osteocyte biomarker in patients with type 2 diabetes (T2DM).
Detailed description
Women with T2DM exhibit normal or higher bone mineral density (BMD) for their age, but with approximately twice the overall risk of bone fragility compared with nondiabetic subjects. Known the apparent association between T2DM and the risk of bone fragility, examining the effects of commonly used oral antidiabetic agents; such as MET and thiazolidinediones (TZDs; for example rosiglitazone [ROS] or PIO), on BMD and/or bone turnover is of great clinical relevance for both diabetic patients and their treating physicians. Recent clinical trials, showed that women treated with ROS had higher risk of bone fragility and self-reported adverse events. Similarly, women on long-term treatment with PIO for T2DM experienced higher incidence of distal extremity fractures. TZDs are agonists of the nuclear transcription factor peroxisome proliferator- activated receptor-γ (PPAR-γ) which increase insulin sensitivity and improve glycemic control in T2DM. PPAR (γ) acts also as a molecular factor that favours adipogenesis over osteoblastogenesis of mesenchymal stem cells. The latter was suggested as a potential mechanism for the effects of TZDs on bone among others. In humans, TZDs decrease BMD and increase bone fragility risk. This study tests whether pioglitazone as compared to MET (both are commonly used in the treatment of T2DM in Saudi Arabia and other countries) affects bone health including bone mineral density, bone turnover markers, and osteocyte biomarker in patients with T2DM.
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 |
|---|---|---|
| Experimental: 1 | Experimental | Drug: PioglitazonePioglitazone given 30mg/once daily for 12 months. |
| Active comparator: 2 | Active comparator | Drug: MetforminMetformin given 850 mg/twice daily for 12 months. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMD T-score greater than -2.5 at the total hip, femoral neck, and lumbar spine;
- No prior antidiabetic therapy;
- Drug-naïve with glycosylated hemoglobin A1c (HbA1c) ≥ 7.0 to ≤ 10.0%. 53.2 mmol/mol to 88.2 mmol/mol);
- Body-mass index of 40 Kg/m2 and less;
- Stable body weight for at least 4 months.
Key exclusion criteria (6 listed)
- Type 1 diabetes mellitus (presence of GAD auto antibodies);
- History of diabetes or uncontrolled hypertension;
- Treatment with antidiabetic agents including TZDs;
- Chronic diseases known to affect bone;
- Previous treatment with estrogens and other medications known to affect bone ;
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 |
|---|---|---|
| PioglitazoneAlso: Actos30 mg/daily for 12 months | Drug | Experimental: 1 |
| MetforminAlso: Glucophage850 mg/daily for 12 months | Drug | Active comparator: 2 |
Primary outcome
Change in mean percentage change in BMD at various sites by Dual energy X-ray absorptiometry(DXA) from baseline and at 6, 12 months in PIO versus MET treatment group.
Time frame: 6-18 months
The primary endpoint was change in mean percentage change in BMD values at the lumbar spine (L1-L4), femoral neck and total hip by DXA from baseline and at 6 and 12 months in the PIO and the MET treatment groups.
1 secondary outcome
Bone turnover Markers and other Biomarkers
Time frame: 6-18 months
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 17 Jun 2014.
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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.
Mohammed-Salleh M Ardawi, PhD, FRCPath principal investigator
Center of Excellence for Osteoporosis Research and Faculty of Medicine, King Abdulaziz University
Abdulrahim A Rouzi, FRCPC study director
Center of Excellence for Osteoporosis Research, and Faculty of Medicine, King Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pioglitazone and Metformin in people with Diabetes Mellitus and Diabetes Mellitus, Type 2, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 6 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 17 Jun 2014. 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 Saudi Arabia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in mean percentage change in BMD at various sites by Dual energy X-ray absorptiometry(DXA) from baseline and at 6, 12 months in PIO versus MET treatment group. (time frame: 6-18 months). 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 17 Jun 2014.