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Also known as Onglyza (saxagliptin), Saxagliptin, BMS-477118, Glucophage
Onglyza · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | 5-mg Onglyza (saxagliptin) tablet +1000-mg Diabex extended release tablet |
| B | EXPERIMENTAL | 5-mg saxagliptin/1000 mg metformin extended release fixed dose combination tablet |
| C | EXPERIMENTAL | 5-mg Onglyza (saxagliptin) tablet + 500-mg Diabex extended release tablet |
| D | EXPERIMENTAL | 5-mg saxagliptin/500 mg metformin extended release fixed dose combination tablet |
| Name | Type | Description |
|---|---|---|
| Onglyza (saxagliptin) | DRUG | Oral tablets, 5 mg , single dose |
| Diabex | DRUG | Extended release oral tablets, 1000 mg, single dose |
| 5-mg saxagliptin/1000 mg metformin | DRUG | Extended release fixed dose combination tablet, single dose |
| 5-mg saxagliptin/500 mg metformin | DRUG | Extended release fixed dose combination tablet, single dose |
Inclusion Criteria: * Provision of signed and dated informed consent prior to any study specific procedures * Males or females aged 18 to 55 years (inclusive) and with a weight of at least 50 kg and a body mass index (BMI) between 18 and 35 kg/m2, inclusive * Females must have a negative urine preg...
Onglyza is used for the treatment of Type 2 Diabetes Mellitus. It is a small molecule medicine developed by AstraZeneca PLC under the ticker AZN. The clinical trial record for Onglyza in this program enrolled 28 healthy adult volunteers in the United States.
Onglyza is made by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the developer associated with the Onglyza (saxagliptin) program for Type 2 Diabetes Mellitus.
Yes. Onglyza is the brand name for saxagliptin, and the product is also written as 2.5 mg ONGLYZA (saxagliptin) tablet. Searches for either Onglyza or saxagliptin refer to the same small molecule medicine developed by AstraZeneca PLC for Type 2 Diabetes Mellitus.
Onglyza is at the Phase 1 stage of clinical development in the trial record for this program. The single listed study, NCT01441869, is a completed Phase 1 trial, so Onglyza is investigational in this development context rather than presented here as an approved product.
Onglyza has been studied in one clinical trial, NCT01441869, titled a study in healthy subjects to measure the amount of drug in blood after dosing with different saxagliptin and metformin products. That Phase 1 trial is completed, enrolled 28 participants, was randomized and controlled, and took place in the United States.
The completed Phase 1 trial NCT01441869 measured bioequivalence using log-transformed AUCss and Cmax,ss values for saxagliptin and metformin. It enrolled 28 healthy volunteers aged 18 years and older of all sexes in the United States, and it was randomized with a controlled design.