MedDataX Logo

Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes

NCT ID: NCT01177813

Last Updated: 2014-06-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

986 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 10773 when given for 24 weeks in patients with T2DM with very poor glycaemic control.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

NCT01289990

Diabetes Mellitus, Type 2
COMPLETED PHASE3

Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

NCT00881530

Diabetes Mellitus, Type 2
COMPLETED PHASE2

Efficacy and Safety of Empagliflozin Versus Sitagliptin in Patients With Type 2 Diabetes

NCT01984606

Diabetes Mellitus, Type 2
WITHDRAWN PHASE3

Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes

NCT01734785

Diabetes Mellitus, Type 2
COMPLETED PHASE3

Phase 1 Bioequivalence Study of Dapagliflozin/Sitagliptin FDC vs Loose Combination of Single Components

NCT05266404

Healthy Volunteers (Intended Indication: Type 2 Diabetes Mellitus)
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BI 10773 low dose

Patients receive BI 10773 low dose tablets once daily

Group Type EXPERIMENTAL

Placebo identical to BI10773 high dose

Intervention Type DRUG

placebo tablets once daily

BI 10773

Intervention Type DRUG

BI 10773 low dose tablet once daily

Placebo identical to Sitagliptin 100mg

Intervention Type DRUG

placebo tablets once daily

BI 10773 high dose

Patients receive BI 10773 high dose tablets once daily

Group Type EXPERIMENTAL

Placebo identical to BI10773 low dose

Intervention Type DRUG

placebo tablets once daily

BI10773

Intervention Type DRUG

BI 10773 high dose tablets once daily

Placebo identical to Sitagliptin 100mg

Intervention Type DRUG

placebo tablets once daily

Placebo

Patients receive tablets identical to those containing BI 10773 low dose and high dose and to Sitagliptin

Group Type PLACEBO_COMPARATOR

Placebo identical to BI10773 low dose

Intervention Type DRUG

placebo tablets once daily

Placebo identical to Sitagliptin 100mg

Intervention Type DRUG

placebo tablets once daily

Placebo identical to BI10773 high dose

Intervention Type DRUG

placebo tablets once daily

Sitagliptin 100 mg

Patients receive Sitagliptin 100 mg tablets once daily

Group Type ACTIVE_COMPARATOR

Placebo identical to BI10773 high dose

Intervention Type DRUG

placebo tablets once daily

Sitagliptin

Intervention Type DRUG

Sitagliptin tablets 100 mg once daily

Placebo identical to BI10773 low dose

Intervention Type DRUG

placebo tablets once daily

BI 10773 high dose open label

Patients receive BI 10773 high dose tablets open label once daily

Group Type EXPERIMENTAL

BI 10773 open label

Intervention Type DRUG

Patients receive BI 10773 high dose tablets open label once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo identical to BI10773 high dose

placebo tablets once daily

Intervention Type DRUG

BI 10773

BI 10773 low dose tablet once daily

Intervention Type DRUG

BI 10773 open label

Patients receive BI 10773 high dose tablets open label once daily

Intervention Type DRUG

Placebo identical to BI10773 low dose

placebo tablets once daily

Intervention Type DRUG

Placebo identical to BI10773 low dose

placebo tablets once daily

Intervention Type DRUG

Placebo identical to BI10773 high dose

placebo tablets once daily

Intervention Type DRUG

Placebo identical to Sitagliptin 100mg

placebo tablets once daily

Intervention Type DRUG

Placebo identical to Sitagliptin 100mg

placebo tablets once daily

Intervention Type DRUG

BI10773

BI 10773 high dose tablets once daily

Intervention Type DRUG

Sitagliptin

Sitagliptin tablets 100 mg once daily

Intervention Type DRUG

Placebo identical to Sitagliptin 100mg

placebo tablets once daily

Intervention Type DRUG

Placebo identical to BI10773 low dose

placebo tablets once daily

Intervention Type DRUG

Placebo identical to BI10773 high dose

placebo tablets once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Diagnosis of type 2 diabetes mellitus prior to informed consent;
2. Male and female patients on diet and exercise regimen who are drug-naïve;
3. HbA1c \>= 7.0% and \<= 10.0% at Visit 1 (screening) for randomised treatment; HbA1c \> 10.0% at visit 1 (screening) for the open-label BI 10773 arm;
4. Age \>= 20 (Japan); Age \>= 18 (countries other than Japan);
5. BMI \<= 45 kg/m2 at Visit 1 (screening);
6. Signed and dated written informed consent by date of Visit 1

Exclusion Criteria

1. Uncontrolled hyperglycaemia;
2. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent;
3. Indication of liver disease, either ALT, AST, or alkaline phosphatase above 3 x ULN;
4. Impaired renal function (eGFR\<50 ml/min);
5. Bariatric surgery within the past two years or other GI surgeries;
6. Medical history of cancer;
7. Contraindications to sitagliptin;
8. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell;
9. Treatment with any anti-diabetes drug within 12 weeks prior to randomisation;
10. Treatment with anti-obesity drugs or any other treatment leading to unstable body weight;
11. Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM;
12. Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and not practicing an acceptable method of birth control;
13. Alcohol or drug abuse;
14. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial;
15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

1245.20.20017 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Site Status

1245.20.20003 Boehringer Ingelheim Investigational Site

Markham, Ontario, Canada

Site Status

1245.20.20009 Boehringer Ingelheim Investigational Site

Newmarket, Ontario, Canada

Site Status

1245.20.20013 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

1245.20.20005 Boehringer Ingelheim Investigational Site

Strathroy, Ontario, Canada

Site Status

1245.20.10124 Boehringer Ingelheim Investigational Site

Mesa, Arizona, United States

Site Status

1245.20.10108 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

1245.20.10150 Boehringer Ingelheim Investigational Site

Hot Springs, Arkansas, United States

Site Status

1245.20.10154 Boehringer Ingelheim Investigational Site

Chino, California, United States

Site Status

1245.20.10009 Boehringer Ingelheim Investigational Site

Santa Ana, California, United States

Site Status

1245.20.10131 Boehringer Ingelheim Investigational Site

West Hills, California, United States

Site Status

1245.20.10038 Boehringer Ingelheim Investigational Site

Northglenn, Colorado, United States

Site Status

1245.20.10137 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1245.20.10006 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1245.20.10085 Boehringer Ingelheim Investigational Site

Plantation, Florida, United States

Site Status

1245.20.10078 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

1245.20.10080 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Site Status

1245.20.10128 Boehringer Ingelheim Investigational Site

Avon, Indiana, United States

Site Status

1245.20.10060 Boehringer Ingelheim Investigational Site

Fishers, Indiana, United States

Site Status

1245.20.10065 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Site Status

1245.20.10117 Boehringer Ingelheim Investigational Site

Arkansas City, Kansas, United States

Site Status

1245.20.10039 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Site Status

1245.20.10146 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Site Status

1245.20.10144 Boehringer Ingelheim Investigational Site

Watertown, Massachusetts, United States

Site Status

1245.20.10115 Boehringer Ingelheim Investigational Site

Brick, New Jersey, United States

Site Status

1245.20.10129 Boehringer Ingelheim Investigational Site

Carlisle, Ohio, United States

Site Status

1245.20.10045 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

1245.20.10119 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

1245.20.10130 Boehringer Ingelheim Investigational Site

Gallipolis, Ohio, United States

Site Status

1245.20.10089 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1245.20.10151 Boehringer Ingelheim Investigational Site

Hurst, Texas, United States

Site Status

1245.20.10155 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1245.20.32008 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1245.20.32011 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1245.20.32023 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1245.20.32003 Boehringer Ingelheim Investigational Site

De Pinte, , Belgium

Site Status

1245.20.32015 Boehringer Ingelheim Investigational Site

Deurne, , Belgium

Site Status

1245.20.32016 Boehringer Ingelheim Investigational Site

Deurne, , Belgium

Site Status

1245.20.32025 Boehringer Ingelheim Investigational Site

Gozée, , Belgium

Site Status

1245.20.32022 Boehringer Ingelheim Investigational Site

Landen, , Belgium

Site Status

1245.20.32019 Boehringer Ingelheim Investigational Site

Leopoldsburg, , Belgium

Site Status

1245.20.32024 Boehringer Ingelheim Investigational Site

Linkebeek, , Belgium

Site Status

1245.20.32021 Boehringer Ingelheim Investigational Site

Mouscron, , Belgium

Site Status

1245.20.32027 Boehringer Ingelheim Investigational Site

Retie, , Belgium

Site Status

1245.20.32020 Boehringer Ingelheim Investigational Site

Sint-Gillis-Waas, , Belgium

Site Status

1245.20.32018 Boehringer Ingelheim Investigational Site

Tielt, , Belgium

Site Status

1245.20.32026 Boehringer Ingelheim Investigational Site

Tremelo, , Belgium

Site Status

1245.20.20011 Boehringer Ingelheim Investigational Site

Chilliwack, British Columbia, Canada

Site Status

1245.20.20018 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Site Status

1245.20.20015 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Site Status

1245.20.20012 Boehringer Ingelheim Investigational Site

Moncton, New Brunswick, Canada

Site Status

1245.20.20016 Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada

Site Status

1245.20.20008 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

Site Status

1245.20.20001 Boehringer Ingelheim Investigational Site

Barrie, Ontario, Canada

Site Status

1245.20.20019 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1245.20.20010 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Site Status

1245.20.20002 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1245.20.20006 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1245.20.20014 Boehringer Ingelheim Investigational Site

Charlottetown, Prince Edward Island, Canada

Site Status

1245.20.20007 Boehringer Ingelheim Investigational Site

Montague, Prince Edward Island, Canada

Site Status

1245.20.20021 Boehringer Ingelheim Investigational Site

Trois-Rivières, Quebec, Canada

Site Status

1245.20.86007 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1245.20.86008 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1245.20.86001 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1245.20.86002 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1245.20.86003 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1245.20.86012 Boehringer Ingelheim Investigational Site

Guiyang, , China

Site Status

1245.20.86020 Boehringer Ingelheim Investigational Site

Hangzhou, , China

Site Status

1245.20.86049 Boehringer Ingelheim Investigational Site

Jinan, , China

Site Status

1245.20.86018 Boehringer Ingelheim Investigational Site

Jingzhou, , China

Site Status

1245.20.86019 Boehringer Ingelheim Investigational Site

Nanchang, , China

Site Status

1245.20.86010 Boehringer Ingelheim Investigational Site

Nanjing, , China

Site Status

1245.20.86043 Boehringer Ingelheim Investigational Site

Nanjing, , China

Site Status

1245.20.86016 Boehringer Ingelheim Investigational Site

Qingdao, , China

Site Status

1245.20.86004 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1245.20.86005 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1245.20.86006 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1245.20.86057 Boehringer Ingelheim Investigational Site

Shenyang, , China

Site Status

1245.20.86017 Boehringer Ingelheim Investigational Site

Shiyan, , China

Site Status

1245.20.86013 Boehringer Ingelheim Investigational Site

Suzhou, , China

Site Status

1245.20.86015 Boehringer Ingelheim Investigational Site

Taiyuan, , China

Site Status

1245.20.86009 Boehringer Ingelheim Investigational Site

Wuhan, , China

Site Status

1245.20.86011 Boehringer Ingelheim Investigational Site

Xi'an, , China

Site Status

1245.20.86014 Boehringer Ingelheim Investigational Site

Xiamen, , China

Site Status

1245.20.49013 Boehringer Ingelheim Investigational Site

Dresden, , Germany

Site Status

1245.20.49016 Boehringer Ingelheim Investigational Site

Düsseldorf, , Germany

Site Status

1245.20.49015 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1245.20.49019 Boehringer Ingelheim Investigational Site

Haag, , Germany

Site Status

1245.20.49020 Boehringer Ingelheim Investigational Site

Hohenmölsen, , Germany

Site Status

1245.20.49014 Boehringer Ingelheim Investigational Site

Köthen, , Germany

Site Status

1245.20.49002 Boehringer Ingelheim Investigational Site

Neuwied, , Germany

Site Status

1245.20.49008 Boehringer Ingelheim Investigational Site

Nuremberg, , Germany

Site Status

1245.20.49017 Boehringer Ingelheim Investigational Site

Saint Ingbert/Oberwürzbach, , Germany

Site Status

1245.20.49022 Boehringer Ingelheim Investigational Site

Schauenburg, , Germany

Site Status

1245.20.49003 Boehringer Ingelheim Investigational Site

Unterschneidheim, , Germany

Site Status

1245.20.91005 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1245.20.91006 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1245.20.91008 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1245.20.91003 Boehringer Ingelheim Investigational Site

Belagavi, , India

Site Status

1245.20.91004 Boehringer Ingelheim Investigational Site

Chennai, , India

Site Status

1245.20.91009 Boehringer Ingelheim Investigational Site

Chennai, , India

Site Status

1245.20.91002 Boehringer Ingelheim Investigational Site

Mumbai, , India

Site Status

1245.20.91007 Boehringer Ingelheim Investigational Site

Mumbai, Maharastra, , India

Site Status

1245.20.91010 Boehringer Ingelheim Investigational Site

Nagpur, , India

Site Status

1245.20.91001 Boehringer Ingelheim Investigational Site

Tamil Nadu, , India

Site Status

1245.20.35302 Boehringer Ingelheim Investigational Site

Co. Cork, , Ireland

Site Status

1245.20.35305 Boehringer Ingelheim Investigational Site

Co. Galway, , Ireland

Site Status

1245.20.35303 Boehringer Ingelheim Investigational Site

Co. Wexford, , Ireland

Site Status

1245.20.35304 Boehringer Ingelheim Investigational Site

Offaly, , Ireland

Site Status

1245.20.35306 Boehringer Ingelheim Investigational Site

Wexford, , Ireland

Site Status

1245.20.81007 Boehringer Ingelheim Investigational Site

Chiyoda-ku, Tokyo, , Japan

Site Status

1245.20.81001 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

1245.20.81002 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

1245.20.81005 Boehringer Ingelheim Investigational Site

Ebetsu, Hokkaido, , Japan

Site Status

1245.20.81004 Boehringer Ingelheim Investigational Site

Kamakura, Kanagawa, , Japan

Site Status

1245.20.81003 Boehringer Ingelheim Investigational Site

Minato-ku, Tokyo, , Japan

Site Status

1245.20.81006 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, , Japan

Site Status

1245.20.81008 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, , Japan

Site Status

1245.20.81009 Boehringer Ingelheim Investigational Site

Suita, Osaka, , Japan

Site Status

1245.20.81010 Boehringer Ingelheim Investigational Site

Ube, Yamaguchi, , Japan

Site Status

1245.20.81012 Boehringer Ingelheim Investigational Site

Urasoe, Okinawa, , Japan

Site Status

1245.20.81013 Boehringer Ingelheim Investigational Site

Urasoe, Okinawa, , Japan

Site Status

1245.20.41004 Boehringer Ingelheim Investigational Site

Lugano, , Switzerland

Site Status

1245.20.41003 Boehringer Ingelheim Investigational Site

Rorschach, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Belgium Canada China Germany India Ireland Japan Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

Reference Type DERIVED
PMID: 38770818 (View on PubMed)

Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

Reference Type DERIVED
PMID: 35472672 (View on PubMed)

Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17.

Reference Type DERIVED
PMID: 27316632 (View on PubMed)

Roden M, Weng J, Eilbracht J, Delafont B, Kim G, Woerle HJ, Broedl UC; EMPA-REG MONO trial investigators. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2013 Nov;1(3):208-19. doi: 10.1016/S2213-8587(13)70084-6. Epub 2013 Sep 9.

Reference Type DERIVED
PMID: 24622369 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-016243-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1245.20

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients
NCT00716092 COMPLETED PHASE2
A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes
NCT03817463 COMPLETED
Study of Safety and Efficacy of PF-04991532 in Subjects With Type 2 Diabetes
NCT01338870 COMPLETED PHASE2
Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus
NCT01336738 COMPLETED PHASE2
Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only
NCT00518115 COMPLETED PHASE2
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.
NCT03169959 COMPLETED PHASE1
BI 10773 add-on to Metformin in Patients With Type 2 Diabetes
NCT00749190 COMPLETED PHASE2
Efficacy and Safety of SYR-472 in Subjects With Type 2 Diabetes Mellitus
NCT00760344 COMPLETED PHASE2
A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin
NCT02551874 COMPLETED PHASE3
An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes
NCT00642278 COMPLETED PHASE2
Dapagliflozin + Saxagliptin in a Basal-bolus Insulin Treatment
NCT02965443 TERMINATED PHASE4
A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus
NCT00477581 COMPLETED PHASE4
Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130)
NCT01177384 COMPLETED PHASE3
Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of MBX-2982 Administered Daily for 4 Weeks as Monotherapy in Patients With Type 2 Diabetes
NCT01035879 COMPLETED PHASE2
Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
NCT00736099 COMPLETED PHASE3
A Study of LY2189265 Compared to Sitagliptin in Participants With Type 2 Diabetes Mellitus on Metformin
NCT00734474 COMPLETED PHASE2/PHASE3
To Assess the Risk of Acute Pancreatitis in Patients With Type 2 Diabetes Mellitus Treated With Empagliflozin
NCT05162014 COMPLETED
Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug
NCT00819091 COMPLETED PHASE3
Safety and Efficacy of Bexagliflozin Compared to Sitagliptin as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
NCT03115112 COMPLETED PHASE3
A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus
NCT02111096 TERMINATED PHASE2
Comparison Study of the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus
NCT01652729 COMPLETED PHASE3
Sitagliptin and Kinetics of Triglyceride-rich Lipoproteins Apolipoprotein B48 and B100 in Patients With Type 2 Diabetes
NCT01334229 COMPLETED PHASE3
A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)
NCT00637273 COMPLETED PHASE3
Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects
NCT03310944 COMPLETED PHASE1
The Efficacy and Safety of Empagliflozin - Linagliptin and Empagliflozin- Metformin Therapy in Reduction of Body Weight in Type 2 Diabetic Patients .
NCT07247656 COMPLETED PHASE4