Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety
Brief Summary: The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.


Options:
A: Arm Label: BI 10773 low (drug naive); Type: EXPERIMENTAL; Interventions: Drug: BI 10773, Drug: Placebo | Arm Label: BI 10773 high (drug naive); Type: EXPERIMENTAL; Interventions: Drug: Placebo, Drug: BI 10773 | Arm Label: Placebo (drug naive); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Sitagliptin 100mg (drug naive); Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Drug: Sitagliptin 100mg | Arm Label: BI 10773 low (pioglitazone); Type: EXPERIMENTAL; Interventions: Drug: BI 10773, Drug: Placebo | Arm Label: BI 10773 high (pioglitazone); Type: EXPERIMENTAL; Interventions: Drug: BI 10773, Drug: Placebo | Arm Label: Placebo (pioglitazone); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: BI 10773 low (metformin); Type: EXPERIMENTAL; Interventions: Drug: Placebo, Drug: BI 10773 | Arm Label: BI 10773 high (metformin); Type: EXPERIMENTAL; Interventions: Drug: BI 10773, Drug: Placebo | Arm Label: Placebo (metformin); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: BI 10773 low (metformin+sulfonylurea); Type: EXPERIMENTAL; Interventions: Drug: BI 10773, Drug: Placebo | Arm Label: BI 10773 high (metformin+sulfonylurea); Type: EXPERIMENTAL; Interventions: Drug: BI 10773, Drug: Placebo | Arm Label: Placebo (metformin+sulfonylurea); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 low (drug naive) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (drug naive) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Sitagliptin 100mg (drug naive) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (drug naive) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 low (metformin) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (drug naive) | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 high (metformin) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (pioglitazone) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Sitagliptin 100mg (drug naive) | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 low (pioglitazone) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (metformin) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 low (pioglitazone) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 high (drug naive) | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 low (metformin) | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 low (metformin+sulfonylurea) | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 high (drug naive) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (metformin) | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 high (metformin+sulfonylurea) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 high (metformin+sulfonylurea) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (pioglitazone) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 low (drug naive) | Intervention Type: DRUG; Name: Sitagliptin 100mg; Assigned to Arm(s): Sitagliptin 100mg (drug naive) | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 high (pioglitazone) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 high (pioglitazone) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (metformin+sulfonylurea) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 high (drug naive) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (metformin+sulfonylurea) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 high (metformin) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 low (metformin+sulfonylurea) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 low (drug naive)
B: Arm Label: voglibose 0.2 mg three times a day (TID); Type: ACTIVE_COMPARATOR; Interventions: Drug: voglibose | Arm Label: BI 1356 low dose; Type: EXPERIMENTAL; Interventions: Drug: BI 1356 | Arm Label: BI 1356 high dose; Type: EXPERIMENTAL; Interventions: Drug: BI 1356 | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: voglibose placebo, Drug: BI 1356 placebo | Intervention Type: DRUG; Name: BI 1356; Assigned to Arm(s): BI 1356 low dose | Intervention Type: DRUG; Name: BI 1356; Assigned to Arm(s): BI 1356 high dose | Intervention Type: DRUG; Name: voglibose placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: BI 1356 placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: voglibose; Assigned to Arm(s): voglibose 0.2 mg three times a day (TID)
C: Arm Label: Strategy A (Glucose-Dependent); Type: EXPERIMENTAL; Interventions: Drug: Metformin, Drug: Pioglitazone, Drug: Acarbose, Drug: Linagliptin, Drug: Sitagliptin, Drug: Liraglutide, Drug: Exenatide once weekly (QW), Drug: Exenatide twice daily (BID) | Arm Label: Strategy B (Reference); Type: ACTIVE_COMPARATOR; Interventions: Drug: Glimepiride, Drug: Metformin, Drug: Pioglitazone, Drug: Acarbose, Drug: Linagliptin, Drug: Sitagliptin, Drug: Insulin Glargine | Intervention Type: DRUG; Name: Glimepiride; Assigned to Arm(s): Strategy B (Reference) | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Strategy A (Glucose-Dependent), Strategy B (Reference) | Intervention Type: DRUG; Name: Pioglitazone; Assigned to Arm(s): Strategy A (Glucose-Dependent), Strategy B (Reference) | Intervention Type: DRUG; Name: Acarbose; Assigned to Arm(s): Strategy A (Glucose-Dependent), Strategy B (Reference) | Intervention Type: DRUG; Name: Linagliptin; Assigned to Arm(s): Strategy A (Glucose-Dependent), Strategy B (Reference) | Intervention Type: DRUG; Name: Sitagliptin; Assigned to Arm(s): Strategy A (Glucose-Dependent), Strategy B (Reference) | Intervention Type: DRUG; Name: Liraglutide; Assigned to Arm(s): Strategy A (Glucose-Dependent) | Intervention Type: DRUG; Name: Insulin Glargine; Assigned to Arm(s): Strategy B (Reference) | Intervention Type: DRUG; Name: Exenatide once weekly (QW); Assigned to Arm(s): Strategy A (Glucose-Dependent) | Intervention Type: DRUG; Name: Exenatide twice daily (BID); Assigned to Arm(s): Strategy A (Glucose-Dependent)
D: Arm Label: Vildagliptin & metformin; Type: EXPERIMENTAL; Interventions: Drug: Vildagliptin, Drug: Metformin | Arm Label: Glibenclamide & metformin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Glibenclamide, Drug: Metformin | Intervention Type: DRUG; Name: Vildagliptin; Assigned to Arm(s): Vildagliptin & metformin | Intervention Type: DRUG; Name: Glibenclamide; Assigned to Arm(s): Glibenclamide & metformin | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Glibenclamide & metformin, Vildagliptin & metformin

Answer: B