A One-year Randomized Controlled Trial Evaluating the Impact of Pioglitazone Versus Linagliptin on Bone Turnover Markers

NCT02429232 | Unknown Phase 4

• 1 other identifier: 201312136MIND
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

Diabetes mellitus is a common disease with much impact on human's health and is related to osteoporosis. But the mechanism remains unclear. The foreign researches revealed thiazolidinedione (TZD) would increase the risk of osteoporosis and bone fracture, specially elderly women. However, it is still controversial in terms of the youth and men. In Taiwan,there is few related study to analyze the relationship between TZD and steoporosis. This is a multicenter randomized controlled study.

Conditions

Osteoporosis; Diabetes Mellitus

Keywords

Pioglitazone; Linagliptin; Diabetes mellitus; Diabetic macular edema; Kidney

Outcome Measures

Primary Outcomes (1)

• Change from baseline in bone turnover markers

  The primary objective is to assess the effect of TZD on skeleton as measured bone turnover markers over the 12 months treatment period.

  Screen, Week 24, 48

Secondary Outcomes (4)

• Change from baseline in Estimated glomerular filtration rate( eGFR)

  Screen, Week 24, 48

• Change from baseline in renal function-serum Creatinine (Cr) level

  Screen, Week 24, 48

• Change from baseline in renal function-Urine Albumin-to-Creatinine Ratio(UACR)

  Screen, Week 24, 48

• Change from baseline in urine biomarkers

  Screen, Week 24, 48

Study Arms (2)

Pioglitazone

EXPERIMENTAL

Pioglitazone 30 mg once daily will be administered orally for total 48 weeks.

Drug: Pioglitazone

Linagliptin

ACTIVE COMPARATOR

Linagliptin 5 mg once daily will be administered orally for total 48 weeks.

Drug: Linagliptin

Interventions

Pioglitazone DRUG

Pioglitazone 30mg/tablet once daily

Also known as: Actos

Pioglitazone

Linagliptin DRUG

Linagliptin 5mg/tablet once daily

Also known as: Trajenta

Linagliptin

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Males or females ≥ 40 years of age at Visit 1and females in postmenopause for one year
• Documentation of type 2 diabetes mellitus as evidenced by one or more of the following criteria:
• With typical symptoms and random blood sugar ≥ 200 mg/dl
• hour fasting blood sugar ≥ 126 mg/dl
• Oral glucose tolerance test ≥ 200 mg/dl
• HbA1c≥ 6.5%
• Only receiving oral anti-diabetic drugs (excluding TZDs or DPP-4 inhibitors) till visit 1 at least 3 months, and the HbA1c is between 7.0\~8.5 % in recent 3 months.
• Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

You may not qualify if:

• DM on oral anti-diabetic drugs less than 3 months.
• Receiving treatment of TZDs or DPP-4 inhibitors prior to this study.
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
• AST, ALT over 2.5 times of the upper limit.
• Chronic kidney disease, stage 4 and 5.
• Congestive heart failure, NYHA class III, IV
• History of osteoporosis.
• History of diseases known to affect bone metabolism:
• Abnormal thyroid function or history of hyperthyroidism, Cushing's syndrome, hypogonadism, acromegaly, history of hypopituitarism or status post pituitary surgery and/or radiotherapy, hematopoietic disorders.
• History of moderate to severe Diabetic macular edema (DME)
• History of moderate to severe diabetic retinopathy.
• History of fracture over lumbar spine or hip joint or femoral head or forearm or any site of bone fracture undergoes treatment currently.
• Who had taken any of the following medications prior to screening:
• Corticosteroid, heparin, anticonvulsants, aluminum-containing antacid, proton pump inhibitor, immunosuppressant user within 3 months. Bisphosphonate, systemic fluoride treatment, PHT analogue, calcitonin, Denosumab, Strontium ranelate, hormone replacement therapy (androgen/estrogen/progesterone, thyroxine, growth hormone), selective estrogen receptor modulator /SERM (Tamoxifene, Raloxifene), selective tissue estrogenic activity regulator /STEAR (Tibolone), aromatase inhibitors within 1 year.
• History of cancer.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Osteoporosis; Diabetes Mellitus

Interventions

Pioglitazone; Linagliptin

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinazolines

Study Officials

• Chin-Hsiao Tseng, MD, PhD

  Department of Medicine,National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng-Jung Nien, MD

CONTACT

886-2-23123456; fj.nien@gmail.com

Chin-Hsiao Tseng, MD, PhD

CONTACT

886-2-23123456; ccktsh@ms6.hinet.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 29, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 27, 2015

Record last verified: 2015-10