Phase 2
Completed N=494
Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01011868 ↗Enrolled (actual)
494
Serious AEs
17.0%
Results posted
Sep 2014
Primary outcomePrimary: Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment — 0.03; -0.58; -0.75 percentage of HbA1c — p=<0.0001
Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 18 Weeks of Treatment |
0.03; -0.58; -0.75 | <0.0001 sig |
| SECONDARY Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5%) After 18, 54 and 78 Weeks of Treatment |
27; 85; 73; 30; 72; 69 | <0.0001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment |
9.81; -14.79; -27.03; 0.91; -9.59; -23.75 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Fasting Plasma Glucose (FPG) After 18, 54 and 78 Weeks of Treatment |
19.02; -2.80; -13.43; 9.67; 0.67; -11.59 | <0.0001 sig |
| SECONDARY Change From Baseline in Basal Insulin Dose/Day After 54 and 78 Weeks of Treatment |
5.39; -1.20; -1.12; 4.79; -0.70; -0.39 | 0.0213 sig |
| SECONDARY Change From Baseline in Body Weight After 18, 54 and 78 Weeks of Treatment |
-0.04; -2.06; -0.91; -0.52; -2.28; -2.23 | 0.0320 sig |
| SECONDARY Change From Baseline in Body Weight at Follow-up |
90.56; 90.44; 93.98; 0.92; -2.02; -1.05 | — |
| SECONDARY Change From Baseline in HbA1c After 54 and 78 Weeks of Treatment |
-0.06; -0.59; -0.84; -0.05; -0.51; -0.68 | <0.0001 sig |
| SECONDARY The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 18, 54, and 78 Weeks of Treatment |
9; 30; 30; 14; 23; 27 | 0.0005 sig |
Eligibility Criteria
Inclusion criteria
- Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation
- Male and female patients with a diagnosis of Type 2 Diabetes Mellitus treated with a stable dose of basal insulin with or without concomitant metformin and / or sulfonylurea.
- Glycosylated hemoglobin A1c (Type A, subtype 1c) of >7.0% and or =18 years at Visit 1 (screening)
- BMI < or = 45 kg/m2 (Body Mass Index) at Visit 1 (screening)
Exclusion criteria
- Patients with poorly controlled hyperglycemia
- Frequent (at the discretion of the investigator) episodes of hypoglycemic events on basal insulin therapy
- MI, stroke, or TIA within 3 months prior to obtaining informed consent
- Impaired hepatic or renal function; gastric surgery; cancer within the last 5 years; blood dyscrasias
- Treatment with other anti-diabetics, anti-obesity medications, steroids or thyroid hormones, participation in another trial with an investigational drug 7. Pre-menopausal women on insufficient birth control 8. Alcohol or drug abuse
Data sourced from ClinicalTrials.gov (NCT01011868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.