Clinical trials: Type Two Diabetes Mellitus
Bioequivalence, Diabetes Mellitus, Type 2
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions.
The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of sitagliptin/metformin extended release tablets after a single oral dose…
- Trial name
- NCT06124573
- Testing
- Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet
- Where
- Mexico
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Galenicum Health
Type 2 Diabetes Mellitus (T2DM)
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg
An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, two way crossover, Oral Bioequivalence Study of test product of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet and…
- Trial name
- NCT07266766
- Testing
- Empagliflozin / Metformin HCl XR Tablets, Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets)
- Where
- India
- Volunteers
- 40 people
- Sponsor
- Humanis Saglık Anonim Sirketi
Type1 Diabetes
Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM
The aim of this trial is to demonstrate bioequivalence of Glaritus® to Lantus® with regard to its total and to its maximum serum insulin concentrations.
- Trial name
- NCT01357603
- Testing
- Glargine
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- Wockhardt
Healthy
Safety and Pharmacokinetics Study of a New Drug for Type 2 Diabetes
The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of GMC-252-L-Lysine Salt in healthy male subjects.
- Trial name
- NCT02686281
- Testing
- GMC-252-L-Lysine
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Genmedica Therapeutics S.L.
Type 2 Diabetes Mellitus
To Compare the Similarity of a Combination Dapagliflozin/Metformin Tablet With the Two Drugs Administered Separately
This is an open-label, randomised study to compare the similarity of a combination Dapagliflozin/Metformin tablet with the two drugs administered separately under fasting and fed conditions in healthy volunteers.
- Trial name
- NCT01535677
- Testing
- Dapagliflozin + Glucophage tablet fasted, Dapagliflozin/metformin IR FDC tablet fasted, Dapagliflozin + Glucophage tablet fed
- Where
- United Kingdom
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Type II Diabetes
A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-378
A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-378
- Trial name
- NCT05741437
- Testing
- CKD-378, QD, PO Drug: D745, D150, QD, PO
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Type 2 Diabetes Mellitus
Insulin Glulisine in Type 2 Diabetes Mellitus
Primary objective: To compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects with type 2 diabetes.
- Trial name
- NCT00310297
- Testing
- Insulin Glulisine
- Sponsor
- Sanofi
Diabetes, Diabetes Mellitus, Type 2
A Trial Comparing the Glycaemic Control of Levemir® Administered Once Daily According to Two Insulin Detemir Titration Algorithms After 20 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Treatment With or Without Other Anti-diabetic Drugs (OADs)
This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of Levemir® (insulin detemir) administered once daily according to two titration algorithms after 20 weeks in subjects with type 2 diabetes…
- Trial name
- NCT01868542
- Testing
- insulin detemir
- Where
- 6 sites in South Korea
- Volunteers
- 46 people
- Sponsor
- Novo Nordisk A/S
Diabetes
Glycemic Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
This will be a randomized, cross-over design. Subjects will be randomized to one of two interventions on two separate study days, 1 week apart.
- Trial name
- NCT02898766
- Testing
- Enteral Nutrition Formula
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Société des Produits Nestlé (SPN)
Type 2 Diabetes Mellitus
A Study to Evaluate the Food Effect on Drug Availability, Pharmacokinetic (PK) Properties, Safety and Tolerability of Two Different Dose Combination Therapy of Saxagliptin/Dapagliflozin/Metformin Extended-release (XR) Against Individual Component Co-administration.
A Study to Assess the Fed-state Bioequivalence of a Triple Fixed-Combination Drug Product (FCDP) of 2.5 mg Saxagliptin / 5 mg Dapagliflozin / 1000 mg Metformin XR and 5 mg Saxagliptin /10 mg Dapagliflozin /1000 mg Metformin XR…
- Trial name
- NCT03169959
- Testing
- 2.5 mg Saxagliptin tablet, 5 mg dapagliflozin / 1000 mg metformin XR tablet, Triple FCDP - 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Diabetes, Diabetes Mellitus, Type 2
Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 Diabetes
This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional…
- Trial name
- NCT01697631
- Testing
- biphasic insulin aspart 30, insulin aspart
- Where
- 12 sites in Poland
- Volunteers
- 131 people
- Sponsor
- Novo Nordisk A/S
Diabetes Mellitus, Type 2
GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension.
- Trial name
- GETGOAL-F1 (NCT00763451)
- Testing
- Lixisenatide (AVE0010), Pen auto-injector, Metformin
- Where
- 15 sites in United States, Brazil and 13 more
- Volunteers
- 484 people
- Sponsor
- Sanofi
Melanoma
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
The purpose of this study is to investigate the pharmacokinetics (PK) similarity of Bmab1700 (an intended nivolumab biosimilar), compared with United States (US)-licensed Opdivo, in participants after complete surgical removal of…
- Trial name
- NCT07476326
- Testing
- Bmab1700, Opdivo
- Where
- 46 sites in Brazil, Chile and 8 more
- Volunteers
- 120 people
- Sponsor
- Biocon Biologics UK PLC
Type2 Diabetes
Evaluation of 2 Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile, in T2D Patients
The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes…
- Trial name
- NCT03289494
- Testing
- Balanced diet high in Slowly Digestible Starch, Balanced diet low in Slowly Digestible Starch
- Where
- France
- Volunteers
- 9 people
- Sponsor
- Mondelēz International, Inc.
Type 2 Diabetes
Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)
This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin 50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of corresponding doses of sitagliptin and…
- Trial name
- NCT01093794
- Testing
- Co-administration of 50 mg sitagliptin and 500 mg metformin, sitagliptin/metformin 50 mg/500 mg tablet, Co-administration of 50 mg sitagliptin and 850 mg metformin
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Diabetic Kidney Disease
Study to Evaluate the Effects of BMS-813160 on Protein Loss in the Urine of Subjects With Type 2 Diabetes and Diabetic Kidney Disease
The purpose of this study is to determine whether BMS-813160 will reduce the amount of protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease
- Trial name
- NCT01752985
- Testing
- BMS-813160
- Where
- 62 sites in United States, Canada and 2 more
- Volunteers
- 319 people
- Sponsor
- Bristol-Myers Squibb
Type 2 Diabetes Mellitus
Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)
This study will establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.
- Trial name
- NCT00944450
- Testing
- Sitagliptin phosphate anhydrous formulation, Comparator: sitagliptin phosphate monohydrate form
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Type 1 Diabetes Mellitus
To Investigate the Efficacy and Safety of Individualized Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 1 Diabetes Mellitus
This is a double-blind, randomised, controlled, two period crossover phase Ib trial using an individualized standard meal with a fixed nutrient ratio in subjects with type 1 diabetes mellitus to investigate postprandial blood…
- Trial name
- NCT02528396
- Testing
- BioChaperone insulin lispro, Humalog®
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- Adocia
Type 1 Diabetes
Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy
Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (52 weeks) for subjects in the "722 Group" is greater than that for subjects in the "Control (MDI) Group".
- Trial name
- STAR3 (NCT00417989)
- Testing
- MiniMed Paradigm REAL-Time System
- Where
- 30 sites in United States, Canada
- Volunteers
- 485 people
- Sponsor
- Medtronic MiniMed, Inc.
Diabetes, Diabetes Mellitus, Type 1
Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial
This trial is conducted in Europe. The aim of the trial is to compare two methods of injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin detemir associated with insulin aspart given twice daily…
- Trial name
- MIXING (NCT00542620)
- Testing
- insulin detemir, insulin aspart
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Novo Nordisk A/S