Phase 3
Completed N=391
Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study)
Source: ClinicalTrials.gov NCT00131664 ↗Enrolled (actual)
391
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcomePrimary: Mean Change From Baseline in A1C at Month 6 — 8.14; 7.96; 7.90; -1.61 percent
Summary
The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes Association guidelines glucose control, based on the A1C measurement, needs to be achieved within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. The guidelines on the use of antihyperglycemic agents identify the potential benefits of sub-maximal oral combination therapy in order to achieve more rapid and improved glycemic control compared with higher dose monotherapy. Furthermore, many patients on prolonged oral antihyperglycemic monotherapy who then start on combination therapy may not achieve the required target glycemic control. Indeed early initiation of combination therapies may be necessary to achieve and maintain glycemic targets because of the progressive deterioration of pancreatic β cell function and glycemic control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in A1C at Month 6 |
8.14; 7.96; 7.90; -1.61; -1.39; -1.02 | — |
| SECONDARY Mean Change From Baseline in A1C at Month 4 |
-1.44; -1.28; -0.94 | — |
| SECONDARY Mean Change From Baseline in A1C at Month 12 |
-1.50; -1.56; -1.14 | — |
| SECONDARY Number of Subjects Achieving A1C Target at Month 4 |
83; 96; 69 | — |
| SECONDARY Number of Subjects Achieving A1C Target at Month 6 |
94; 98; 69 | — |
| SECONDARY Number of Subjects Achieving A1C Target at Month 12 |
95; 111; 82 | — |
| SECONDARY Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 4 |
-2.86; -2.33; -1.75 | — |
| SECONDARY Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 |
-2.98; -2.55; -1.86 | — |
| SECONDARY Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12 |
-2.71; -2.76; -2.12 | — |
| SECONDARY Number of Subjects Achieving FPG Target at Month 4 |
58; 65; 38 | — |
| SECONDARY Number of Subjects Achieving FPG Target at Month 6 |
61; 76; 43 | — |
| SECONDARY Number of Subjects Achieving FPG Target at Month 12 |
64; 86; 51 | — |
| SECONDARY Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 6 |
-1.09; -1.05; -1.54 | — |
| SECONDARY Mean Change From Baseline in 5 Year UKPDS Risk Scores at Month 12 |
-0.72; -0.62; -1.11 | — |
| SECONDARY Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 |
-1.20; -1.68; -1.25 | — |
| SECONDARY Mean Change From Baseline in C-reactive Protein (CRP) at Month 12 |
-0.40; -1.52; -1.52 | — |
| SECONDARY Mean Change From Baseline in Adiponectin at Month 6 |
5.73; 6.37; 0.23 | — |
| SECONDARY Mean Change From Baseline in Adiponectin at Month 12 |
4.95; 8.21; 1.453 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes patients
- 18 - 75 years old
- Type 2 diabetes mellitus (DM) drug naïve or on submaximal oral monotherapy 2.5 times upper limit of normal)
- Renal impairment: serum creatinine ≥ 136umol/L (males) and ≥ 124 umol/L (females)
- Congestive Heart Failure (CHF class III/IV)
- Weight >160 kg
Data sourced from ClinicalTrials.gov (NCT00131664). 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.