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30 Studies found for: Recruiting, Not yet recruiting, Available Studies | "Hypoglycemic Agents"

Also searched for Antidiabetics and Hypoglycemics. See Search Details

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Recruiting, Not yet recruiting, Available Studies | "Hypoglycemic Agents" (30 records)

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NCT02671864

Recruiting

Incretin-mimetic Hypoglycemic Drugs and Severe Retinopathy

Type 2 Diabetes

Other: 1: incretin-based therapy
Other: 2: other antidiabetic

Interventional

Not Applicable

Assistance Publique - Hôpitaux de Paris
Assistance Publique Hopitaux De Marseille
Institut National de la Santé Et de la Recherche Médicale, France
(and 6 more...)

Other

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other

Prevalence of Severe DR at V1 (inclusion)
Prevalence of severe DR at V2 (after 3 years of treatment)
Plasma concentrations of ANGPT4
(and 3 more...)

7200

All

18 Years and older (Adult, Older Adult)

NCT02671864

P150601

ANGIOSAFE 2

April 11, 2016

April 11, 2022

February 2, 2016

August 29, 2017

Hôpital de la Conception
Marseille, France
Département de Diabétologie - Hopital Lariboisière
Paris, France

NCT02885922

Recruiting

The Effects of add-on Anti-diabetic Drugs in Type 2 Diabetic Patients

Hyperglycemia

Drug: anti-diabetic drug

Observational

Taichung Veterans General Hospital

Other

Observational Model: Cohort
Time Perspective: Prospective

HbA1c
Brain-Derived Neurotrophic Factor (BDNF)
Body-composition
(and 5 more...)

6000

All

20 Years and older (Adult, Older Adult)

NCT02885922

CG16183A

September 2016

December 2020

September 1, 2016

March 27, 2018

outpatient clinic of the Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Taichung, Taiwan

NCT02925559

Not yet recruiting

Effect of Anti-diabetic Drugs on Glycemic Variability

Diabetes Mellitus, Type 2

Drug: Dapagliflozin
Drug: Gliclazide MR

Interventional

Phase 4

Centro de Diabetes Curitiba Ltda
AstraZeneca

Other / Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Glycemic Variability
Glycated hemoglobin A1c (HbA1c) measured as percentage (%)
Fasting plasma glucose (FPG) measured by hexokinase method (mg/dL)
(and 6 more...)

120

All

40 Years and older (Adult, Older Adult)

NCT02925559

ESR-14-10377

EFFORT

October 2016

December 2017

October 6, 2016

Centro de Diabetes Curitiba
Curitiba, Parana, Brazil

NCT02695121

Recruiting

Cancer in Patients on Dapagliflozin and Other Antidiabetic Treatment

Breast Cancer
Bladder Cancer

Observational

AstraZeneca

Industry

Observational Model: Cohort
Time Perspective: Retrospective

Incidence of breast cancer
Incidence of bladder cancer
Incidence of compsite cancer outcomes

99999

All

Child, Adult, Older Adult

NCT02695121

D1690R00007
EUPAS12116

February 29, 2016

April 30, 2024

March 1, 2016

June 11, 2018

Research Site
Wilmington, Delaware, United States
Research Site
Washington, District of Columbia, United States
Research Site
Utrecht, Netherlands
Research Site
London, United Kingdom

NCT02695082

Recruiting

Acute Kidney Injury in Patients on Dapagliflozin and Other Antidiabetic Medications

Acute Kidney Injury

Observational

AstraZeneca

Industry

Observational Model: Cohort
Time Perspective: Retrospective

Incidence of Acute Kidney injury (AKI)

91927

All

Child, Adult, Older Adult

NCT02695082

D1690R00004
EUPAS11684

February 29, 2016

November 30, 2019

March 1, 2016

June 11, 2018

Research Site
Wilmington, Delaware, United States
Research Site
Washington, District of Columbia, United States
Research Site
London, United Kingdom

NCT02336217

Recruiting

Glycemic Emergency Management (GEM); An App for Rapid Response to Hypoglycemic and Hyperglycemic Situations

Diabetes Mellitus

Other: Experimental Group instructions for glucose management via App
Other: Placebo Comparator general instructions

Interventional

Not Applicable

Marshall University
Richmond Gyamfi, MD, Larry Dial, MD, Prasanna Santhanam, MD, Anise Nash, APRN

Other

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Number of hypoglycemic episodes
A1c level
Number of Emergency Room, Urgent Care, or Walk-In Clinic visits
ADDQOL score

All

18 Years to 70 Years (Adult, Older Adult)

NCT02336217

574049

GEMApp

September 2014

September 2019

January 12, 2015

June 7, 2017

Marshall Health
Huntington, West Virginia, United States

NCT03485222

Recruiting

Are the "Cardiac Benefits" of Empagliflozin Independent of Its Hypoglycemic Activity? (ATRU-4).

Cardiovascular Diseases

Drug: Empagliflozin
Drug: Placebos

Interventional

Phase 4

Icahn School of Medicine at Mount Sinai
Boehringer Ingelheim
Eli Lilly and Company

Other / Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Left Ventricle-end systolic volume (ESV)
LV-end diastolic volume (EDV)
LV-Ejection Fraction index
(and 3 more...)

All

18 Years and older (Adult, Older Adult)

NCT03485222

GCO 17-2457

EMPA-TROPISM

May 31, 2018

December 2020

April 2, 2018

May 14, 2018

Mount Sinai Heart - Icahn School of Medicine at Mount Sinai
New York, New York, United States

NCT03010956

Recruiting

Changes in Arterial Stiffness and Endothelial Glycocalyx in Patients With Poorly Controlled Diabetes Mellitus Type 1 or Type 2 After Optimization of Antidiabetic Medication.

Diabetes Mellitus

Observational

University of Athens

Other

Observational Model: Case-Crossover
Time Perspective: Prospective

Differences in pulse wave velocity at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
Differences in augmentation index at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
Differences in endothelial glycocalyx at baseline and 3, 6 and 12 months after the modification of the antidiabetic medication.
(and 3 more...)

All

18 Years to 70 Years (Adult, Older Adult)

NCT03010956

S-DM-ATTIKON

November 2014

June 2017

November 2017

January 5, 2017

''Attikon'' University General Hospital
Haidari, Athens, Attiki, Greece

NCT03172494

Recruiting

A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)

Diabetes
Diabetes Mellitus, Type 2

Drug: Insulin degludec/liraglutide
Drug: Insulin degludec
Drug: Liraglutide

Interventional

Phase 3

Novo Nordisk A/S

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Change in HbA1c (glycosylated haemoglobin)
Change in body weight
Number of treatment emergent severe or blood glucose (BG) confirmed hypoglycaemic episodes
(and 24 more...)

720

All

18 Years and older (Adult, Older Adult)

NCT03172494

NN9068-4148
U1111-1154-6671
CTR20170004

DUAL™ I China

May 26, 2017

December 10, 2018

July 29, 2019

June 1, 2017

June 18, 2018

Novo Nordisk Investigational Site
He Fei, Anhui, China
Novo Nordisk Investigational Site
Beijing, Beijing, China
Novo Nordisk Investigational Site
ChongQing, Chongqing, China
(and 33 more...)

NCT03434119

Recruiting

Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents

Type 2 Diabetes Mellitus

Drug: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)
Drug: Insulin glargine (HOE901)

Interventional

Phase 3

Sanofi

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Change in HbA1c
Patients with HbA1c<7%
Change in 2-hour post-prandial glucose (PPG)
(and 5 more...)

1200

All

18 Years and older (Adult, Older Adult)

NCT03434119

LPS14860
U1111-1200-1891

LixiLan-D

February 20, 2018

April 23, 2019

February 15, 2018

May 18, 2018

Investigational Site Number 8400013
Little Rock, Arkansas, United States
Investigational Site Number 8400015
Los Angeles, California, United States
Investigational Site Number 8400011
Los Angeles, California, United States
(and 30 more...)

NCT03492580

Recruiting

A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease

Diabetes Mellitus, Type 2
Cardiovascular Diseases

Drug: Canagliflozin
Drug: Empagliflozin
Drug: Dapagliflozin
(and 6 more...)

Observational

Janssen Research & Development, LLC

Industry

Observational Model: Cohort
Time Perspective: Retrospective

Number of Hospitalizations for Heart Failure
Number of Participants with Below Knee Lower Extremity Amputation Events

714582

All

Child, Adult, Older Adult

NCT03492580

CR108464
RRA-20250

February 22, 2018

June 30, 2018

April 10, 2018

Janssen Investigative Site
Titusville, New Jersey, United States

NCT02855684

Recruiting

Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy

Type 2 Diabetes Mellitus

Drug: Insulin glargine (U300)
Drug: Insulin glargine
Drug: Non-insulin antihyperglycemic drugs

Interventional

Phase 3

Sanofi

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Change in HbA1c from baseline
Percentage (%) of patients with at least one hypoglycemia
Percentage (%) of patients with at least one nocturnal hypoglycemia
(and 10 more...)

600

All

18 Years and older (Adult, Older Adult)

NCT02855684

EFC12814
U1111-1139-3894

EDITION AP

August 24, 2016

August 6, 2018

August 4, 2016

June 18, 2018

Investigational Site Number 1560039
Beijing, China
Investigational Site Number 1560001
Beijing, China
Investigational Site Number 1560017
Beijing, China
(and 52 more...)

NCT00658021

Recruiting

Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes

Type 2 Diabetes

Drug: Placebo
Drug: Exenatide

Interventional

Phase 3

AstraZeneca
Quintiles, Inc.

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

The primary objective of this study is to test the hypothesis that glycemic control with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients
The primary endpoint is change in A1c from baseline compared to placebo.
The secondary objectives of the study are to evaluate the difference between exenatide and placebo with respect to glycemic, weight, and safety assessments.
(and 7 more...)

195

All

10 Years to 17 Years (Child)

NCT00658021

D5550C00002

May 30, 2008

March 10, 2020

March 6, 2023

April 14, 2008

June 6, 2018

Research Site
Birmingham, Alabama, United States
Research Site
Tucson, Arizona, United States
Research Site
Los Angeles, California, United States
(and 102 more...)

NCT03269058

Not yet recruiting

Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes

Type-2 Diabetes
Oral Antidiabetics

Drug: Dapagliflozin
Drug: Placebos

Interventional

Phase 4

Centre Hospitalier Universitaire Dijon

Other

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Change from baseline the rate of production of VLDL Apo B
Change from baseline the rate of production of IDL Apo B
Change from baseline the rate of production of LDL Apo B
(and 6 more...)

All

30 Years to 65 Years (Adult, Older Adult)

NCT03269058

VERGES AZ 2015

Cinétique DAPA

September 2017

March 2019

August 31, 2017

CHU Dijon Bourgogne
Dijon, France
CHU de Nantes
Nantes, France

NCT01897688

Recruiting

A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients

Type 1 Diabetes
Severe Hypoglycemic Unawareness

Biological: Islet Cell Transplant

Interventional

Phase 3

Northwestern University

Other

Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

To demonstrate the safety and efficacy of islet transplantation under alemtuzumab induction for treatment of Type-1 Diabetes (T1D) in subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes.
To relate clinical transplant outcomes based upon islet quantity/quality to organ donor characteristics.

All

18 Years to 65 Years (Adult, Older Adult)

NCT01897688

STU00059469

June 2012

March 2020

March 2021

July 12, 2013

April 20, 2018

Northwestern University
Chicago, Illinois, United States

NCT03448965

Not yet recruiting

Hypoglycemic and Hyperglycemic Disorders

Hypoglycemia in Newborn Infants
Hyperglycemia

Diagnostic Test: random blood sugar

Observational

Assiut University

Other

Observational Model: Other
Time Perspective: Cross-Sectional

glycemic disorders in low birth weight

100

All

up to 28 Days (Child)

NCT03448965

NGD

December 15, 2018

October 20, 2019

December 31, 2019

February 28, 2018

NCT02231021

Recruiting

The Practical Evidence of Antidiabetic Combination Therapy in Korea

Type 2 Diabetes Mellitus

Drug: alogliptin
Drug: Pioglitazone
Drug: alogliptin + pioglitazone

Interventional

Phase 4

Kun-Ho Yoon
Takeda
The Catholic University of Korea

Other / Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Change in glycohemoglobin(HbA1c) from baseline
Proportion of subjects achieving HbA1c < 7.0%
Proportion of subjects achieving HbA1c <6.5%
(and 21 more...)

300

All

19 Years to 75 Years (Adult, Older Adult)

NCT02231021

ALO-IIT-012

PEAK

September 2014

June 2018

November 2018

September 3, 2014

July 14, 2017

Seoul St Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of

NCT02926937

Recruiting

Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus Not Currently Treated With Antidiabetic Therapy

Type 2 Diabetes Mellitus

Drug: Sotagliflozin (SAR439954)
Drug: Placebo

Interventional

Phase 3

Sanofi

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Change from Baseline in HbA1c in comparison of sotagliflozin dose 1 versus placebo
Change from baseline in 2-hour PPG following a mixed meal in comparison of sotagliflozin doses 1 and 2 versus placebo
Change from baseline in FPG in comparison of sotagliflozin dose 1 versus placebo
(and 6 more...)

400

All

18 Years and older (Adult, Older Adult)

NCT02926937

EFC14833
2016‐001799‐31
U1111-1180-6169

November 11, 2016

March 29, 2019

October 6, 2016

June 18, 2018

Investigational Site Number 8401049
Tucson, Arizona, United States
Investigational Site Number 8401026
Tucson, Arizona, United States
Investigational Site Number 8401028
Anaheim, California, United States
(and 61 more...)

NCT03285594

Recruiting

Efficacy and Safety of Sotagliflozin Versus Placebo in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents

Type 2 Diabetes Mellitus

Drug: sotagliflozin (SAR439954)
Drug: insulin glargine (HOE901)
Drug: Placebo

Interventional

Phase 3

Sanofi

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Change in HbA1c
Change in Fasting Plasma Glucose
Change in Systolic Blood Pressure (SBP) for patients with Baseline SBP ≥130 mmHg
(and 3 more...)

560

All

18 Years and older (Adult, Older Adult)

NCT03285594

EFC14868
2016‐001804‐43
U1111-1190-7567

SOTA-INS

September 15, 2017

August 9, 2019

September 18, 2017

June 1, 2018

Investigational Site Number 8406028
Mesa, Arizona, United States
Investigational Site Number 8406013
Phoenix, Arizona, United States
Investigational Site Number 8406020
Phoenix, Arizona, United States
(and 97 more...)

NCT03175120

Recruiting

A Trial Comparing Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other Oral Antidiabetic Drug (OAD)

Diabetes
Diabetes Mellitus, Type 2

Drug: Insulin degludec/liraglutide
Drug: Insulin degludec

Interventional

Phase 3

Novo Nordisk A/S

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Change in HbA1c (glycosylated haemoglobin)
Change in body weight
Number of treatment emergent severe or blood glucose confirmed hypoglycaemic episodes
(and 22 more...)

450

All

18 Years and older (Adult, Older Adult)

NCT03175120

NN9068-4166
U1111-1154-6732
CTR20060909

DUAL™ II China

May 26, 2017

December 10, 2018

May 13, 2019

June 5, 2017

June 18, 2018

Novo Nordisk Investigational Site
Hefei, Anhui, China
Novo Nordisk Investigational Site
Hefei, Anhui, China
Novo Nordisk Investigational Site
Beijing, Beijing, China
(and 35 more...)

NCT03241706

Not yet recruiting

Liver Glycogen and Hypoglycemia in Humans

Hypoglycemia; Iatrogenic

Drug: Fructose
Drug: Saline
Drug: Somatostatin
(and 3 more...)

Interventional

Phase 1

Jason Winnick
University of Cincinnati

Other

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science

Epinephrine
Glucagon
Glucose Infusion Rate
(and 3 more...)

All

21 Years to 40 Years (Adult)

NCT03241706

2016-7982

September 1, 2017

May 31, 2021

May 31, 2022

August 7, 2017

NCT03006510

Not yet recruiting

Hypoglycemia Prediction Model

Hypoglycemia

Other: Hypoglycemia prediction alert

Interventional

Early Phase 1

University of California, San Francisco

Other

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention

The proportion of patients (in each group) who ultimately have a hypoglycemic event

6500

All

18 Years and older (Adult, Older Adult)

NCT03006510

16-20565

January 2017

January 2018

July 2018

December 30, 2016

NCT02695095

Recruiting

Acute Liver Injury in Patients on Dapagliflozin

Acute Liver Injury

Observational

AstraZeneca

Industry

Observational Model: Cohort
Time Perspective: Retrospective

incidence of acute liver injury

91927

All

Child, Adult, Older Adult

NCT02695095

D1690R00005

February 29, 2016

November 30, 2019

March 1, 2016

June 11, 2018

Research Site
Wilmington, Delaware, United States
Research Site
Washington, District of Columbia, United States
Research Site
London, United Kingdom

NCT02695173

Recruiting

Complications of UTI in Patients on Dapagliflozin

Severe Complications of Urinary Tract Infections

Observational

AstraZeneca

Industry

Observational Model: Cohort
Time Perspective: Retrospective

Incidence of urinary tract infections (UTI) complications
Incidence of pyelonephritis

91927

All

Child, Adult, Older Adult

NCT02695173

D1690R00008
EUPAS12113

February 29, 2016

November 30, 2019

March 1, 2016

June 11, 2018

Research Site
Wilmington, Delaware, United States
Research Site
Washington, District of Columbia, United States
Research Site
London, United Kingdom

NCT02163044

Recruiting

The Hellenic Postprandial Lipemia Study (HPLS)

Coronary Heart Disease
Dyslipidemia

Observational

Hellenic College of Treatment of Atherosclerosis

Other

Observational Model: Other
Time Perspective: Prospective

Change in CRP levels
Change in exaggerated postprandial lipemia
Change in Lipotest meal values
Number of major adverse cardiovascular events

1200

All

18 Years to 90 Years (Adult, Older Adult)

NCT02163044

2014-HPLS-IIS

HPLS

September 2014

June 2018

June 13, 2014

March 7, 2018

Onassion Cardiology Hospital
Athens, Greece

NCT01733459

Recruiting

Efficacy and Safety of DLBS3233 in Subjects With Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome (PCOS)

Drug: DLBS3233
Drug: Metformin XR
Drug: Placebo caplet of Metformin XR
Drug: Placebo capsule of DLBS3233

Interventional

Phase 3

Dexa Medica Group

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

HOMA-IR reduction
Reduction of S/A ratio
Reduction of free testosterone level (calculated)
(and 9 more...)

124

Female

18 Years to 40 Years (Adult)

NCT01733459

DLBS3233-0811

March 2013

April 2018

June 2018

November 27, 2012

November 27, 2017

Department of Obstetrics and Gynecology, Faculty of Medicine, University of Padjadjaran, Hasan Sadikin Hospital
Bandung, West Java, Indonesia
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Faculty of Medicine, University of Indonesia, dr. Cipto Mangunkusumo Hospital
Jakarta, Indonesia

NCT02953665

Recruiting

Safety and Efficacy of Liraglutide in Parkinson's Disease

Parkinson Disease

Drug: Liraglutide
Drug: Placebo

Interventional

Phase 2

Cedars-Sinai Medical Center
The Cure Parkinson's Trust
Novo Nordisk A/S

Other / Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Motor Function
Non-Motor Function
Cognitive Function
(and 4 more...)

All

25 Years to 85 Years (Adult, Older Adult)

NCT02953665

U1111-1173-0106

April 3, 2017

July 2019

September 2019

November 3, 2016

April 17, 2018

Cedars Sinai Medical Center
Los Angeles, California, United States

NCT02844153

Recruiting

Metformin Use in Chronic Kidney Disease: The CKD-Met Study

Type 2 Diabetes
Chronic Kidney Disease

Other: modalities of metformin prescription

Observational

Hospices Civils de Lyon

Other

Observational Model: Cohort

Percentage of patients receiving metformin
Dose of metformin
Occurence of reasons for non-prescription of metformin
(and 4 more...)

1000

All

18 Years and older (Adult, Older Adult)

NCT02844153

69HCL16_0408

CKD-Met

March 2014

March 2018

March 2020

July 26, 2016

Claude Bernard University, Lyon, France, Lyon Sud university hospital
Pierre-Bénite, France

NCT02864953

Not yet recruiting

Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction

Brain Edema
Stroke, Acute

Drug: BIIB093
Drug: Placebo

Interventional

Phase 3

Biogen

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Proportion of Participants with Improvement in Functional Outcome at Day 90 Assessed via the Modified Rankin Scale (mRS)
Time to All-Cause Death
Proportion of Participants Who Achieved mRS 0-4 at Day 90
(and 2 more...)

680

All

18 Years to 85 Years (Adult, Older Adult)

NCT02864953

252LH301
RPI 301
2017-004854-41

CHARM

June 29, 2018

September 28, 2020

June 28, 2021

August 12, 2016

March 22, 2018

NCT01258075

Recruiting

Colesevelam Pediatric Type 2 Diabetes Mellitus Study

Type 2 Diabetes Mellitus

Drug: Welchol for oral suspension placebo proxy
Drug: Welchol for oral suspension

Interventional

Phase 4

Daiichi Sankyo, Inc.

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Mean change in hemoglobin A1c from baseline (day 1) to 6 months
Mean change in fasting plasma glucose from baseline (day 1) to 6 months
Percentage of participants with HbA1c decreasing >= 0.7% from baseline (day 1) to 6 months
(and 3 more...)

230

All

10 Years to 17 Years (Child)

NCT01258075

WEL-A-U307

WELKid DM

November 2010

June 2019

December 10, 2010

December 27, 2017

Tucson, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
(and 21 more...)

† Study has passed its completion date and status has not been verified in more than two years.

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