Completed Clinical Trials


4433 - Weight Loss Study

4433: Investigation of safety and efficacy of NNC0174-0833 for weight management – a dose finding trial. The 4433 trial is designed to determine the dose of NNC0174-0833, which is optimal for weight management. NNC0174-0833 is a long-acting amylin analogue designed for weight management treatment. Different doses of NNC0174-0833 will be compared against placebo and Liraglutide 3.0 mg. Liraglutide 3.0 mg is included to enable comparisons of NNC0174-0833 with a weight management product (Saxenda®) that is approved in several countries. The primary objective is to compare the dose-response of increasing doses of NNC0174-0833 once weekly (OW) versus placebo and versus Liraglutide 3.0 mg once daily (OD) on body weight, in subjects with overweight or obesity, when added as an adjunct to a reduced-calorie diet and increased physical activity.


SCORED

SCORED: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function.The SCORED trial tests whether medication, Sotagliflozin, is safe in people with diabetes and kidney disease, and those at risk for cardiovascular events, such as heart attack and stroke. The purpose of the study is to show that Sotagliflozin does not increase the risk of a heart attack, stroke, being hospitalized for heart failure, or mortality from a cardiovascular event.

 


PERL

PERL: A Multicenter Clinical Trial of Allopurinol to Prevent Renal Function (GFR) Loss in Type 1 Diabetes. PERL is a multi-center, international, randomized, placebo-controlled trial that explores whether a medication, Allopurinol, can prevent kidney problems, in particular the loss of kidney function, in people with Type-1 diabetes.


DARE-Bands: Diabetes Aerobic and REsistance-Bands trial

DARE-Bands was a 6-month long clinical research study targeted at people with Type-2 Diabetes Mellitus (T2DM), aged > 35 years, who are not already meeting current guidelines for physical activity. The study compares the effects of aerobic training only, aerobic training plus primarily supervised group-based resistance bands training, and aerobic training plus primarily home-based resistance bands training on glycemic control as reflected by hemoglobin A1c. Strength, body composition, heart disease risk factors, and quality of life of participants involved were also monitored.


DEAL: Diabetes Exercise And Lifestyle trial

DEAL was a clinical study exploring the effects of different strategies in helping people with T2DM increase their physical activity, and the effects on blood sugar control, other heart disease risk factors, body composition, and quality of life. The main goal of the study was to determine the effects of supervised combined aerobic and resistance training, and the effects of stage-matched written materials delivered by mail and pedometers with step logs, alone or in combination, on glycemic control, as reflected in A1C, in a one-year intervention.


DECLARE: Dapagliflozin Effect on CardiovascuLAR Events

DECLARE was a multicenter, randomized, double blind, placebo-controlled Phase 3b study to evaluate whether treatment with Dapagliflozin reduces major adverse cardiovascular events in patients with T2DM and a known cardiovascular disease, or T2DM patients with at least two risk factors for cardiovascular disease. This study sought to definitively exclude unacceptable cardiovascular risk in these patients from Dapagliflozin.


EASE-3: Empagliflozin as Adjunctive to Insulin Therapy over 26 weeks in Patients with T1DM trial

The EASE-3 trial explores whether new medication, Empagliflozin, is effective in the treatment of Type-1 Diabetes Mellitus (T1DM). Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors (Sodium GLucose co-Transporter-2). These medications work by causing glucose to be excreted in urine.


E-PAraDiGM: Exercise-Physical Activity Diabetes Glucose Monitoring (E-PAraDiGM) Protocol

E-PAraDiGM was a weeklong clinical trial examining the effect of a single bout of walking on glucose levels in people with T2DM. Using a randomized crossover design, participants completed the E-PAraDiGM Protocol, which involves two two-day intervention periods (Walking vs. Control) separated by 24 hours over the course of 6 days. A continuous glucose monitor CGM (CGMS iPro2, Medtronic) was initiated on Day 1 of the protocol.


ProMetic: A Phase 2, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of PBI-4050 in Type 2 Diabetes Mellitus Patients with Metabolic Syndrome

The study was sponsored by ProMetic Pharma SMT Ltd. The primary objectives of this clinical research study were to evaluate the efficacy of PBI-4050 400 mg, 800 mg, and 1200 mg, administered orally once daily for 12 weeks, to reduce hemoglobin A1c (HbA1c) levels and to evaluate the safety of PBI-4050 in people with inadequately controlled Type-2 Diabetes Mellitus (T2DM) and metabolic syndrome (T2DMS) when compared with placebo. The secondary objectives were to assess the effect of PBI-4050 on body weight, waist circumference, blood pressure (BP), and heart rate, the effect of PBI-4050 on fasting blood glucose levels, fasting insulin, fasting C-peptide levels, to evaluate the effect of PBI-4050 on frequency of hypoglycemia events and to evaluate the effect of PBI-4050 on pro inflammatory/inflammatory and diabetic biomarkers in blood and urine.


READI: Resistance Exercise in Already-active Diabetic Individuals trial

READI was a 6 month trial involving research participants who are already aerobically active but not weight training or resistance training.  The main purpose of this study was to determine the effects of resistance training on metabolic control, blood pressure and quality of life, of aerobically active patients with Type-1 Diabetes, and to compare these effects with a non-resistance training control. After a run-in period, to assess compliance, participants were randomly assigned to resistance exercise, or a control group.  The resistance exercise group was required to attend exercise resistance sessions 3 times per week (2 of the 3 sessions was with the study personal trainer), and complete exercise logs.  Those randomized to the control group continued to exercise as much as they did before entering the study.  In either case, patients continued aerobic exercise at their usual volume and intensity.


REMIT-DAPA: Remission Evaluation of Metabolic Interventions in Type 2 Diabetes with Forxiga

Approximately 1 in 10 adults in Canada currently have diagnosed diabetes. Recent research suggests that it may be possible to reverse diabetes or put it into remission using intensive lifestyle therapy and short-term combination drug therapy with injectable insulin and oral diabetes medications. This trial tested whether a short treatment with insulin glargine (Lantus), metformin, Dapagliflozin (Forxiga) and lifestyle was able to achieve prolonged diabetes remission. The study included 152 people with Type-2 Diabetes, and took place at several research centers in Canada.


REMIT-SITA: An open-label, randomized, parallel design trial to compare the efficacy of a sitagliptin-based metabolic intervention versus standard diabetes therapy in inducing remission of T2DM

Approximately 1 in 10 adults in Canada currently have diagnosed diabetes. Recent research suggests that it may be possible to reverse diabetes or put it into remission using intensive lifestyle therapy and short-term combination drug therapy with injectable insulin and oral diabetes medications. This trial explored whether a short treatment with insulin glargine (Lantus), metformin/Sitagliptin (Janumet) and lifestyle was able to achieve prolonged diabetes remission. The study included 100 people with Type-2 Diabetes, and took place at several research centers in Canada.


T1-DARE: Type 1 Diabetes Aerobic and Resistance Exercise trial

T1-DARE aimed to explore the effects of resistance training and aerobic training, on glycemic control in previously inactive individuals with Type-1 Diabetes. The trial involved background therapy meeting modern standards, including multiple daily injections or insulin pump, carbohydrate (CHO) counting, frequent glucose monitoring, and utilization of glucose monitoring to adjust CHO and insulin for exercise.