Effect of Anti-diabetic Drugs on Bone Metabolism and Glycemic Variability
NCT ID: NCT01679899
Last Updated: 2016-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
56 participants
INTERVENTIONAL
2012-12-31
2015-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A total of 38 women with documented Type 2 Diabetes and menopause will be enrolled. The active treatment will include a 50 mg dose of vildagliptin OD twice a day. As comparator, gliclazide MR will be administered at a dose of 60 to 120 mg OD once a day.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Target population of clinical trial subjects A total of 38 women with documented Type 2 Diabetes and menopause will be enrolled. To be as close to a real life scenario as possible, clinical trial subjects which are treated with glucose-lowering medication (except incretin or sulfonylurea based therapies) and treatment-naive subjects will be included.
Investigational Product, posology and method of administration The active treatment will include a 50 mg dose of vildagliptin OD twice a day.
Comparator, posology and method of administration As comparator, gliclazide MR will be administered at a dose of 60 to 120 mg OD once a day.
Treatment duration The study will have an expected total duration of 18 months, 12 months of active treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vildagliptin
Vildagliptin 50 mg bid for 12 months
Vildagliptin
Vildagliptin 50mg bid orally for 12 months
Gliclazide MR
Gliclazide MR 60 or 120mg once a day for 12 months
Gliclazide MR
Gliclazide MR 60 or 120mg orally for 12 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vildagliptin
Vildagliptin 50mg bid orally for 12 months
Gliclazide MR
Gliclazide MR 60 or 120mg orally for 12 months
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* All study subjects must be women diagnosed with type 2 diabetes based on current guidelines of Sociedade Brasileira de Diabetes (SBD - Brazilian Society of Diabetes) and/or American Society of Diabetes (ADA) and they should have all the following criteria:
* Age ≥ 40 years old.
* HbA1c ≥ 6.5% at randomization.
* Menopause defined as:
* Absence of menstruation for at least 12 months in patients with an intact uterus, or
* FSH level greater than 30 mIU/mL in a hysterectomized patient and/or,
* FSH level greater than 30 mIU/mL in a patient with surgical menopause.
Exclusion Criteria
* Patient on chronic dialysis and/or renal transplantation and/or serum creatinine \> 1.5 mg/dL.
* Patients with HIV, severe autoimmune disease or chronic treatment with oral steroids (\> 30 consecutive days).
* Current or previous treatment (within 6 months) with incretin (DPP-IV inhibitor or GLP-1 analog) within 6 months prior to randomization.
* Current or previous treatment with pioglitazone or rosiglitazone within 12 months prior to randomization.
* Sustained arterial hypertension \> 180/100 mm Hg.
* Body mass index (BMI) \> 50 kg/m².
* HbA1c ≥ 9,5% at randomization.
* Transaminases (AST (SGOT) and ALT (SGPT)) \> 2.5 x upper limit of normal.
* Chronic liver disease or alcoholic liver disease.
* LDL-cholesterol \> 250 mg/dL (\> 6.48 mmol/L).
* Triglycerides \> 1000 mg/dL (\> 11.3 mmol/L).
* HDL-cholesterol \< 25 mg/dL (\< 0.64 mmol/L).
* Levels of 25-OH-vitamin D \< 20ng/mL at randomization
* Abnormal levels of PTH, cortisol, IGF-1 or GH at randomization
* Prescription of any investigational medication within one year before the screening visit (visit 1), unless there is a direct benefit to the study subject, at the discretion of the investigator.
* History of previous fracture
* Pregnant or breastfeeding patients.
* Previous participation on this study.
* Individuals at risk for poor adherence to the protocol or medication.
* Any condition that makes the patient unable to complete the study within 12 months.
40 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centro de Diabetes Curitiba Ltda
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andre GD Vianna, MD
Role: STUDY_CHAIR
Centro de Diabetes Curitiba
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centro de Diabetes Curitiba
Curitiba, Paraná, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Vianna AGD, de Lacerda CS, Pechmann LM, Polesel MG, Marino EC, Borba VZC, Barreto FC. Vildagliptin has the same safety profile as a sulfonylurea on bone metabolism and bone mineral density in post-menopausal women with type 2 diabetes: a randomized controlled trial. Diabetol Metab Syndr. 2017 May 15;9:35. doi: 10.1186/s13098-017-0232-2. eCollection 2017.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BoneGlyc
Identifier Type: -
Identifier Source: org_study_id