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Type II Diabetes Mellitus clinical trials

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NCT ID: NCT03907202 Terminated - Clinical trials for Type II Diabetes Mellitus

A Clinical Study to Evaluate the Safety, Tolerability, PK, PD, and Efficacy of KBP-089 in Patients With T2DM

Start date: April 17, 2018
Phase: Phase 1
Study type: Interventional

KeyBioscience is developing KBP-089, a dual activator of both the amylin and calcitonin receptors, for the treatment of type II diabetes mellitus, using a subcutaneous injectable mode of administration. This is a double-blind, placebo-controlled, randomised, multiple-ascending dose phase I trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of KBP-089 in patients with type 2 diabetes, who are on stable therapy with metformin. Subjects will receive daily subcutaneous injections in the abdomen over a period of 28 days. The planned maximum doses of KBP-089 to be investigated in the trial are 20 µg in cohort 1, 60 µg in cohort 2, and 150 µg in cohort 3. For cohort 1, the dose is planned to be escalated every 7 ±1 days, and for cohort 2 and cohort 3, every 3 days. Doses may be modified according to individual tolerability, but the dose regimen will not exceed 28 days. The IMP is administered by daily subcutaneous injections taken in the morning before breakfast. The trial is performed in Germany and at least 36 patients will be enrolled in the trial. The trial will be randomised 1:1:1 between maximum doses of KBP-089 of 20 µg, 60 µg, 150 µg and placebo. Within each of the three cohorts, 12 patients will be randomised 3:1 to KBP-089 and placebo.

NCT ID: NCT02749435 Terminated - Clinical trials for Type II Diabetes Mellitus

A Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With Type 2 Diabetes Mellitus

Start date: May 3, 2016
Phase: N/A
Study type: Observational

A real-world, point-of-care, randomized, parallel group, open, 6-month clinical study to evaluate if the provision of a digital disease management tool improves glycaemic control in participants with type 2 diabetes mellitus (T2DM), as measured by change from baseline to End of Study (Month 6) in glycosylated haemoglobin (HbA1c) levels. Clinical assessments for this study will be conducted as part of normal, standard care. The main objective of this study is to evaluate the effect of adding this tool to participants' current standard care for T2DM on glycaemic control, other variables of importance in T2DM (eg, weight, blood pressure, and lipid levels), and participant-reported outcomes (PROs), such as satisfaction with treatment and adherence to their antihyperglycaemic treatment

NCT ID: NCT02492763 Terminated - Clinical trials for Type II Diabetes Mellitus

A Preliminary Study of the Efficacy and Safety of MK-8521 for Type 2 Diabetes (MK-8521-004)

Start date: July 27, 2015
Phase: Phase 2
Study type: Interventional

This is a multicenter randomized, double-blind, placebo- and active-controlled (liraglutide; Victoza®), parallel-group, clinical trial of MK-8521 in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control while on a stable dose of metformin (≥1000 mg/day). The trial will include a 1-week screening period; at least an 8-week antihyperglycemic agent (AHA) washout period, if required; a 14-week blinded therapy period (which includes single-blind run-in and double-blind therapy); and a 14-day post-treatment visit, 2 weeks after the last dose of investigational product. The primary hypothesis of the trial is that MK-8521 provides greater reduction in hemoglobin A1C relative to placebo after 12 weeks of once-daily administration in participants with T2DM with inadequate glycemic control on metformin monotherapy.

NCT ID: NCT02274740 Terminated - Clinical trials for Type II Diabetes Mellitus

Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients

Start date: April 2015
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the ability of lixisenatide to modulate postprandial hyperlipidemia in particular, the effects on plasma changes in triglycerides. Secondary Objectives: The effect of lixisenatide on the following postprandial lipids: apolipoprotein (APO) B48; free fatty acid, lipoprotein distribution, cholesterol, and low-density lipoprotein (LDL) oxidation. The effect of lixisenatide on chronic low-grade inflammation present in non-insulin dependent diabetes mellitus (NIDDM) and obesity. The effect of lixisenatide on microvascular dysfunction. To evaluate the effect of lixisenatide on postprandial plasma glucose, insulin and C-peptide and glucagon.

NCT ID: NCT01644201 Terminated - Obesity Clinical Trials

A Study Evaluating the Effects of a High Viscosity Non-starch Polysaccharide (PolyGlycopleX® - PGX®) on Glycemic Control, Cardiometabolic Risk Factors and Weight Loss in Overweight and Obese Type II Diabetics

Start date: October 2012
Phase: Phase 3
Study type: Interventional

One out of two adults in Canada is currently overweight and therefore at increased risk for a number of medical conditions including diabetes, high blood pressure, heart attacks and stroke. Obesity is less prevalent in populations consuming large amounts of dietary fibre, suggesting that fibre intake could play an important role in prevention and progression of obesity and diabetes and other conditions. Several studies have suggested that fibre has a positive effect on blood sugar and may help lower body weight. The purpose of this study is to help better understand the effect of adding fibre supplementation to a low calorie diet on blood sugar control and weight loss. The investigators hypothesize that blood sugar control will improve in participants in the fibre supplementation group. Men and women, with stable Type 2 Diabetes (e.g. no medication change in the last 3 months), between 18 - 75 years of age, and with a Body Mass Index (BMI) between 27 - 60 kg/m2 can participate in this study.

NCT ID: NCT01514838 Terminated - Clinical trials for Type II Diabetes Mellitus

A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus

Start date: April 23, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C as well as its safety in Asian subjects with type 2 diabetes mellitus.

NCT ID: NCT00997152 Terminated - Clinical trials for Type II Diabetes Mellitus

Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients

Start date: September 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of JTT-654 on diabetes as well as the safety, tolerability and pharmacokinetics of JTT-654 in type 2 diabetic patients.