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Study on the Correlation of dapagliflozin with Vitamin D, K2 in Diabetes Mellitus

Study on the Correlation of dapagliflozin with Vitamin D, K2 in Diabetes Mellitus

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046532
Enrollment
Unknown
Registered
2021-05-21
Start date
2022-02-01
Completion date
Unknown
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

Dapagliflozin Group:Dapagliflozin
Metformin+Dapagliflozin Group:Metformin+Dapagliflozin

Sponsors

Weishan People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Follow the study center's dietary regimen; 2.HbA1C is less than 9%; 3.Aged 30 to 65 years. 4.Weight >=50kg; 5.Sign and date written informed consent prior to study enrollment in accordance with GCP and local laws.

Exclusion criteria

Exclusion criteria: 1.Any previous history of fracture; 2.Previous history of osteoporosis and while taking medication; 3.Taking vitamin D preparations; 4.Have had gastrointestinal surgery (except appendectomy); 5.Central nervous system disease (such as epilepsy) or mental disorders or neurological disorders; 6.Associated postural hypotension, history of dizziness or vertigo; 7.Chronic or associated acute infections; 8.History of related allergies/hypersensitivity reactions (including 1. Allergies to drugs or their excipients); 9.Taking a long-life drug for at least one month before or during the study or for less than 10 half-lives of the corresponding drug; 10.Participated in trials of other study drugs within 2 months prior to study administration or during the trial; 11.Drug abuse; 12.Blood donation (more than 100 mL within 4 weeks prior to study administration or during the trial); 13.Excessive physical activity (within 1 week prior to study administration or during study period); 14.Patients taking sGLT-2 inhibitors and hypoglycemic drugs; 15.Baseline QT/QTc intervals were significantly longer (for example, QTc intervals were repeatedly greater than 450 ms); 16.A history of urinary and reproductive diseases and acute urinary tract infection.

Design outcomes

Primary

MeasureTime frame
Vitamin D;Vitamin K2;

Countries

China

Contacts

Public ContactLi Xiaoe

Weishan People's Hospital

xeli66@163.com+86 15315378176

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026