Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Repaglinide Versus Metformin Treatment in Combination With Insulin Biasp30 (Novologmix 70/30) Predinner on Glycemic and Non-Glycemic Cardiovascular Risk-Factors in Non-Obese Patients With Type-2-Diabetes With Unsatisfactory Glycaemic Control With Oral Hypoglycaemic Agents
Brief Summary: Aim:

The United Kingdom Prospective Diabetes Study (UKPDS) showed a reduction in cardiovascular events in obese patients with type-2-diabetes treated with metformin compared with other hypoglycaemic treatments with no difference in glycemic control between treatments. Non-obese patients with type-2-diabetes are usually treated with insulin-secretagogues or insulin when diet fails. Since non-obese patients with type-2-diabetes also carry a high risk of cardiovascular events, the use of metformin for this sub-group of patients might be more beneficial. Moreover, when insulin-treatment is initiated ongoing oral hypoglycaemic agents (OHA) are often continued, but in non-obese patients with type-2 diabetes little evidence exist for choosing the optimal class of OHA to be combined with insulin. The aim of the project is therefore to investigate the effect of metformin vs. an insulin-secretagogue (repaglinide) in combination with insulin on glycemic control and non-glycemic cardiovascular risk-factors in non-obese patients with type-2-diabetes, uncontrolled on diet alone.

Methodology:

Single-center, double-blind, double-dummy, randomized, parallel study involving 100 non-obese (BMI 27 kg/m2 or lower) patients with type-2-diabetes investigating the effect of treatment with metformin vs. repaglinide each in combination with biphasic insulin (Insulin-aspart 30/70, BIAsp30) for a period of 12 months.


Options:
A: Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin, Drug: Insulin BIAsp30 (Novolog 70/30), Drug: Placebo-Repaglinide | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Insulin BIAsp30 (Novolog 70/30), Drug: Repaglinide, Drug: Placebo-Metformin | Arm Label: 1; Type: OTHER; Interventions: Drug: Metformin, Drug: Repaglinide | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): 1, 3 | Intervention Type: DRUG; Name: Insulin BIAsp30 (Novolog 70/30); Assigned to Arm(s): 2, 3 | Intervention Type: DRUG; Name: Repaglinide; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Placebo-Metformin; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Placebo-Repaglinide; Assigned to Arm(s): 3
B: Arm Label: Blood pressure; Type: PLACEBO_COMPARATOR; Interventions: Drug: Perindopril-indapamide | Arm Label: Glucose control; Type: OTHER; Interventions: Drug: Gliclazide MR-based glucose lowering | Intervention Type: DRUG; Name: Perindopril-indapamide; Assigned to Arm(s): Blood pressure | Intervention Type: DRUG; Name: Gliclazide MR-based glucose lowering; Assigned to Arm(s): Glucose control
C: Arm Label: Vildagliptin; Type: EXPERIMENTAL; Interventions: Drug: Vildagliptin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Vildagliptin; Assigned to Arm(s): Vildagliptin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Intervention Type: DRUG; Name: Metformin on top of intensive insulin therapy; Assigned to Arm(s): N/A

Answer: A