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Type 2 Diabetes Mellitus clinical trials

View clinical trials related to Type 2 Diabetes Mellitus.

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NCT ID: NCT01991197 Completed - Clinical trials for Type 2 Diabetes Mellitus

Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial.

DIP
Start date: April 2014
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to determine if sitagliptin (Januvia®) improves psoriasis severity after 16 weeks of treatment in 20 participants with both psoriasis and type 2 diabetes mellitus. We will compare the change in psoriasis severity in 20 participants treated with Januvia® to 20 participants treated with 16 weeks of a comparator drug (gliclazide, Diamicron®). Participants will be recruited from two centres and after a 4 week washout period will be followed prospectively for 36 weeks. Participants will be stratified by centre, psoriasis severity and obesity status after which they will be randomly allocated to Arm A or Arm B. Participants will be treated with either Januvia® and Diamicron® matched placebo capsules (Arm A), or Diamicron® and Januvia® matched placebo tablets (Arm B) for 16 weeks and then proceed to an open-label phase where all participants will receive Januvia® for a further 16 weeks. Both the research participants and the investigators will be unaware of the trial arm to which the research participant has been allocated (double-blind study). Research participants will be prohibited from making any changes to the dose of medications used to treat psoriasis. If a participant's plasma glycated haemoglobin level (HbA1c) (reflects a participant's glucose control over the previous 3 months) is above 64mmol/mol eight weeks after commencing one of the study investigational medicinal products (IMPs) insulin therapy will be used to improve glycaemic control. Participants will be assessed at 9 study visits over 40 weeks. Participants will complete questionnaires, have a medical history recorded and physical examination, blood sampling and skin biopsies taken (in a small number of willing participants at 3 visits). The following endpoints will be analysed: Changes in psoriasis severity at 16 and 32 weeks; changes in validated quality of life scores; incidence of adverse events; incidence of discontinuation of one of the study IMPs, time to relapse of psoriasis; changes in cardiovascular disease risk factor profiles; changes in cytokines, hormones, expression of immune proteins in blood and skin biopsies; and genetic profiles that predicts best response to sitagliptin therapy. We hypothesize that sitagliptin therapy decreases psoriasis severity.

NCT ID: NCT01990300 Completed - Clinical trials for Type 2 Diabetes Mellitus

Alogliptin/Pioglitazone (Liovel) Combination Tablets Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus

Start date: November 28, 2011
Phase:
Study type: Observational

The purpose of this survey is to examine the safety and efficacy of long-term use of alogliptin/pioglitazone(Liovel) combination tablets in patients with type 2 diabetes mellitus determined as warranting combination therapy with alogliptin benzoate and pioglitazone hydrochloride

NCT ID: NCT01987258 Completed - Clinical trials for Type 2 Diabetes Mellitus

The Acute Effect of Interval-walking

acute IWS
Start date: June 2013
Phase: N/A
Study type: Interventional

Four months of interval walking training (IWT) is superior to energy-expenditure matched continuous walking training (CWT) with regards to weight loss and improvements in glycemic control. The reason for this is unclear. One potential explanation for the differential outcome in weight loss is excess post-exercise oxygen consumption (EPOC), which is defined as the elevated oxygen consumption measured during the hours following an exercise bout. A large EPOC means greater energy expenditure which, if energy intake does not change, leads to a greater weight loss. This weight loss may subsequently improve glycemic control - Aim 1: To assess the effect of an acute bout of IWT vs. an acute bout of CWT on glycemic control in type 2 diabetics and to assess mechanisms responsible for differences (if any). It is hypothesised that IWT will be more advantageous for improving glycemic control. - Aim 2: To examine the effect of an acute bout of IWT vs. an acute bout of CWT on EPOC. It is hypothesised that IWT will produce an EPOC of larger magnitude than CWT.

NCT ID: NCT01986881 Completed - Clinical trials for Type 2 Diabetes Mellitus

Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004)

Start date: November 4, 2013
Phase: Phase 3
Study type: Interventional

An overall study of the cardiovascular outcomes following treatment with ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and established vascular disease. The main objective of this study is to assess the cardiovascular safety of ertugliflozin. This trial includes 3 pre-defined glycemic sub-studies; 1. In participants receiving background insulin with or without metformin, 2. In participants receiving background sulfonylurea monotherapy, and 3. In participants receiving background metformin with sulfonylurea (all fully-enrolled). Participants enrolled prior to Amendment 1 were in the overall study as well as a sub-study, if they met certain entry criteria. Participants enrolled following the start of Amendment 1 were only enrolled in the overall study. The sub-studies were the initial 18 weeks of the overall study period.

NCT ID: NCT01986855 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study of the Efficacy and Safety of Ertugliflozin in Participants With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Antihyperglycemic Therapy (MK-8835-001)

Start date: December 2, 2013
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in participants with Type 2 diabetes mellitus with Stage 3 Chronic Kidney Disease (CKD) who have inadequate glycemic control on background antihyperglycemic therapy. The duration of this trial will be up to 67 weeks. This study will consist of a 1-week Screening Period, a 10-week wash-off period from metformin, if needed, and a 2-week placebo run-in period, a 52-week double-blind treatment period, and a 14-day post-treatment follow-up period. The primary objective of this trial is to assess the hemoglobin A1C (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides greater reduction in A1C compared to the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin.

NCT ID: NCT01972893 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZYD1, Following Subcutaneous Administration in Healthy Volunteers

ZYD1
Start date: February 2011
Phase: Phase 1
Study type: Interventional

ZYD1 is a novel GLP-1 receptor agonist. The ZYD1 exhibits increased stability to proteolytic cleavage, especially against dipeptidyl peptidase-4 (DPP-IV). ZYD1 is a potent antidiabetic agent without gastrointestinal side-effects. A first in human (FIH) Phase I study intends to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZYD1 in normal healthy adult volunteers.

NCT ID: NCT01971554 Completed - Clinical trials for Type 2 Diabetes Mellitus

Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-8666 in Participants With Type 2 Diabetes Mellitus (MK-8666-003)

Start date: October 14, 2013
Phase: Phase 1
Study type: Interventional

This is a study of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-8666 in participants with type 2 diabetes mellitus (T2DM). Participants enrolled in this trial would be either treatment-naive or have washed off of oral anti-hyperglycemic agents. MK-8666 is planned to be administered orally for up to 2 weeks. The primary hypothesis for this study is that after 14 days of once daily treatment with MK-8666, at a dose that is safe and well tolerated, the placebo-corrected fasting plasma glucose reduction from baseline is ≥34 mg/dL.

NCT ID: NCT01968265 Completed - Clinical trials for Type 2 Diabetes Mellitus

Safety, Tolerability and Efficacy of ISIS-GCCRRx in Type 2 Diabetes

Start date: October 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx in combination with metformin versus placebo + metformin

NCT ID: NCT01964963 Completed - Clinical trials for Type 2 Diabetes Mellitus

Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus

Start date: August 3, 2011
Phase:
Study type: Observational

The purpose of this study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.

NCT ID: NCT01963663 Completed - Clinical trials for Type 2 Diabetes Mellitus

Metformin and Pioglitazone Effects on YKL-40 Concentrations in Type 2 Diabetes Patients

Start date: November 2012
Phase: N/A
Study type: Interventional

Patients with type 2 diabetes are at an increased risk for developing atherosclerosis, largely due to the underlying insulin resistance and chronic low grade inflammation. Cardiovascular events could be prevented with proper interventions targeted at ameliorating the aforementioned detrimental processes. YKL-40, a novel surrogate marker of acute and chronic inflammatory states has been implicated to have a putative role in both pathways. Given the shared pathway of insulin resistance and atherosclerosis, it is conceivable that anti-diabetes medications are able to modify coronary artery disease risk via direct and indirect amelioration of YKL-40 concentrations. The present clinical trial was therefore launched to examine the comparative effects of metformin and pioglitazone, two commonly prescribed anti-diabetes medications on YKL-40 concentrations in medication-naïve, newly-diagnosed type 2 diabetes patients.