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The primary objective is to demonstrate the non-inferiority at six months of a basal plus one insulin regimen (Lantus plus one injection of Apidra) compared with a biphasic insulin regimen (NovoMix 30) at controlling glycosylated haemoglobin (HbA1c) in type 2 diabetes.
The secondary objective are:
- To compare the proportion of patients in each treatment group reaching HbA1c target (< 7%) at the end of the treatment period
- To compare the rates of hypoglycaemia (total, severe, nocturnal)
- To compare the change in body weight from visit 10 to visit 24
- To compare the change in diabetes specific quality of life and other patient reported outcomes from visit 10 to visit 24
- Diabetes Treatment Satisfaction Questionnaire - status and change (DTSQs+c)
- Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire
- Insulin Treatment Satisfaction Questionnaire (ITSQ)
- EuroQoL 5 Dimensions (EQ5D) questionnaire
- To record the change in the daily dose of insulin from visit 2 to visit 10 and visit 10 to visit 24
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Diabetes Mellitus, Type 2
INSULIN GLARGINE (HOE901), Insulin aspart, Insulin Glulisine
Sanofi-Aventis Investigational Site Number 205
Published on BioPortfolio: 2014-08-27T03:19:49-0400
This trial is conducted in Europe. The aim of this clinical trial is to compare the 24-hour pharmacodynamics/ pharmacokinetics of biphasic insulin aspart 30 (BiAsp 30) thrice daily treatme...
The purpose of this study is to compare the change in glycemic control, as measured by hemoglobin A1c (HbA1c) from baseline to study week 24, in subjects receiving insulin glulisine as mea...
This trial is conducted in Europe. The objective of the study is to investigate the effect and safety of continously basal delivered Insulin Aspart given by a pump versus once daily inject...
This trial is conducted in the United States of America (USA). The purpose of this study is to determine if the use of insulin detemir in combination with insulin aspart is safe and at lea...
The purpose of this study is to test for superiority in improvements from baseline in patient reported outcomes in subjects with type 1 or type 2 diabetes when treated with insulin glargin...
Compare safety and efficacy of fast-acting insulin aspart (faster aspart) with conventional insulin aspart (IAsp) in adults with type 1 diabetes (T1D).
To assess the impact of duration of prior basal insulin therapy on study outcomes in people with type 2 diabetes mellitus receiving insulin glargine 300 U/mL (Gla-300) or insulin glargine 100 U/mL (Gl...
Insulin glargine, a long-acting human insulin analogue, allows for once-daily basal use in patients with type 1 diabetes mellitus (T1DM). MYL-1501D is a proposed insulin glargine biosimilar.
We compared the efficacy of insulin detemir and biphasic insulin aspart-30 given in the morning as an add-on to oral hypoglycemic agents (OHAs) in type 2 diabetic patients.
To evaluate the glycemic control achieved by prandial once daily insulin glulisine injection timing adjustment based on continuous glucose monitoring sensor in comparison to once daily insulin glulisi...
A recombinant LONG ACTING INSULIN and HYPOGLYCEMIC AGENT that is used to manage BLOOD GLUCOSE in patients with DIABETES MELLITUS.
A syndrome with excessively high INSULIN levels in the BLOOD. It may cause HYPOGLYCEMIA. Etiology of hyperinsulinism varies, including hypersecretion of a beta cell tumor (INSULINOMA); autoantibodies against insulin (INSULIN ANTIBODIES); defective insulin receptor (INSULIN RESISTANCE); or overuse of exogenous insulin or HYPOGLYCEMIC AGENTS.
Insulin that has been modified to contain an ASPARTIC ACID instead of a PROLINE at position 38 of the B-chain.
Diminished effectiveness of INSULIN in lowering blood sugar levels: requiring the use of 200 units or more of insulin per day to prevent HYPERGLYCEMIA or KETOSIS. It can be caused by the presence of INSULIN ANTIBODIES or the abnormalities in insulin receptors (RECEPTOR, INSULIN) on target cell surfaces. It is often associated with OBESITY; DIABETIC KETOACIDOSIS; INFECTION; and certain rare conditions. (from Stedman, 25th ed)
A 51-amino acid pancreatic hormone that plays a major role in the regulation of glucose metabolism, directly by suppressing endogenous glucose production (GLYCOGENOLYSIS; GLUCONEOGENESIS) and indirectly by suppressing GLUCAGON secretion and LIPOLYSIS. Native insulin is a globular protein comprised of a zinc-coordinated hexamer. Each insulin monomer containing two chains, A (21 residues) and B (30 residues), linked by two disulfide bonds. Insulin is used as a drug to control insulin-dependent diabetes mellitus (DIABETES MELLITUS, TYPE 1).