Does an approved treatment for type 2 diabetes decrease the risk of fractures in patients with type 2 diabetes?

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 19.0Level: LLTClassification code 10029505Term: Non-insulin-dependent diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-001284-40-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-24
• Last Update Posted: 3 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Informed consent
Diagnosis of type 2 diabetes (HbA1c higher than 48 mmol/mol)
Postmenopausal (2 years since last menstrual bleeding)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Type 1 diabetes
Treatment with insulin
Body weight higher than 140 kg
Treatment with GLP-1 analogues, DPP-4 inhibitors, or glitazones
Chronic kidney disease
Hepatic disease
Pancreatitis
Inflammatory bowel disease
Osteoporosis
Family or personal history of medullary thyroid carcinoma
Treatment with glucocorticoids
Hormone replacement therapy
Diabetic gastroparesis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aims of the study are to investigate the effect of the GLP-1 analogue liraglutide (Victoza) in postmenopausal women with type 2 diabetes on bone turnover, bone mass, and bone structure.;Secondary Objective: not applicable;Primary end point(s): Reduction in the bone resorption marker collagen I cross-linked C-terminal telopeptide measured in serum.;Timepoint(s) of evaluation of this end point: Days 0, 7, 28, 90 and 180

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in the bone formation markers bone alkaline phosphatase, osteocalcin, and procollagen type I N-terminal propeptide.<br>Change in BMD.<br>Change in bone structure evaluated by QCT and HRpQCT.<br>Change in HbA1c.;Timepoint(s) of evaluation of this end point: Alkaline phosphatase, osteocalcin, and procollagen type I N-terminal propeptide, and HbA1c: days 0, 7, 28, 90 and 180.<br>BMD and change in bone structure: days 0, 90 and 180.