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Insuman Comb 25 vs Novolin 30R in Type 2 Diabetes
NCT01353469Phase 3
Key facts
- Status
- Completed
- Start
- May 2011
- Primary completion
- Nov 2012
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Biologic, Hormone, rProtein (Recombinant Protein)
- Drugs
- insuman comb 25
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, open-label trial of insuman comb 25 in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Sanofi. Primary endpoint: Change in HbA1c from baseline to the end of treatment at 24 weeks. Started May 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Insuman Comb 25
Insuman Comb 25 self-injected subcutaneously twice daily 30-45 minutes before breakfast and dinner.
Novolin 30R
Novolin 30R self-injected subcutaneously twice daily within 30 minutes before breakfast and dinner.
03
Who it enrols
Patients with type 2 diabetes mellitus for at least 1 year, currently on premix insulin therapy (with or without OADs), with HbA1c between 7% and 10% and regular self-monitoring of blood glucose.
04
Endpoints
Primary
Change in HbA1c from baseline to the end of treatment
Secondary
Change in fasting plasma glucose from baseline to the end of treatment
Safety and tolerability of Insuman Comb 25 versus Novolin 30R
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