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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01676220
Other study ID # EFC12347
Secondary ID 2012-000146-35U1
Status Completed
Phase Phase 3
First received August 28, 2012
Last updated May 28, 2015
Start date August 2012
Est. completion date March 2014

Study information

Verified date May 2015
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Primary Objective:

To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus

Secondary Objectives:

To compare a new formulation of insulin glargine and Lantus in terms of:

- occurrence of nocturnal hypoglycemia


Description:

The maximum study duration was up to approximately 54 weeks per participant, consisting of:

- Up to 2 week screening period; it can be exceptionally extended of up to one additional week

- 6-month comparative efficacy and safety treatment period

- 6-month comparative safety extension period

- 2-day post-treatment safety follow-up period


Recruitment information / eligibility

Status Completed
Enrollment 878
Est. completion date March 2014
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria :

- Adult participants with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s);

- Signed written informed consent.

Exclusion criteria:

- HbA1c less than (<) 7.0% (< 53 millimole per mole [mmol/mol]) or greater than (>) 11% (> 97 mmol/mol)

- History of type 2 diabetes mellitus for less than 1 year before screening

- Less than 6 months before screening with non-insulin antihyperglycemic treatment

- Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening

- Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of Glucagon-like peptide-1 (GLP-1) receptor agonist in the last 6 months before screening visit

- Participants receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinide (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin, sulfonylurea and glinide are to be discontinued at baseline)

- Current or previous insulin use except for a maximum of 8 consecutive days (for example, acute illness, surgery) during the last year prior to screening

- Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (for example, laser, surgical treatment or injectable drugs) during the study period

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
HOE901-U300 (new formulation of insulin glargine)
HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]).
Lantus (insulin glargine)
Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

Locations

Country Name City State
Bulgaria Investigational Site Number 100205 Blagoevgrad
Bulgaria Investigational Site Number 100203 Byala
Bulgaria Investigational Site Number 100201 Plovdiv
Bulgaria Investigational Site Number 100204 Plovdiv
Bulgaria Investigational Site Number 100206 Sofia
Canada Investigational Site Number 124204 Brampton
Canada Investigational Site Number 124211 Etobicoke
Canada Investigational Site Number 124208 Laval
Canada Investigational Site Number 124214 London
Canada Investigational Site Number 124210 Montreal
Canada Investigational Site Number 124218 Montreal
Canada Investigational Site Number 124206 Pointe-Claire
Canada Investigational Site Number 124219 Sherbrooke
Canada Investigational Site Number 124201 Thornhill
Canada Investigational Site Number 124209 Thornhill
Canada Investigational Site Number 124212 Toronto
Canada Investigational Site Number 124216 Ville St-Laurent
Czech Republic Investigational Site Number 203201 Brno
Czech Republic Investigational Site Number 203205 Brno
Czech Republic Investigational Site Number 203204 Havirov
Czech Republic Investigational Site Number 203203 Praha 10
Czech Republic Investigational Site Number 203202 Praha 8
Denmark Investigational Site Number 208205 Ålborg
Denmark Investigational Site Number 208203 Esbjerg
Denmark Investigational Site Number 208209 Hellerup
Denmark Investigational Site Number 208202 Herlev
Denmark Investigational Site Number 208206 Hvidovre
Denmark Investigational Site Number 208207 København Nv
Denmark Investigational Site Number 208210 Kolding
Denmark Investigational Site Number 208201 Odense C
Denmark Investigational Site Number 208204 Viborg
Estonia Investigational Site Number 233204 Tallinn
Estonia Investigational Site Number 233203 Tartu
Estonia Investigational Site Number 233205 Tartu
Finland Investigational Site Number 246208 Helsinki
Finland Investigational Site Number 246202 Kokkola
Finland Investigational Site Number 246207 Oulu
Finland Investigational Site Number 246206 Tampere
Finland Investigational Site Number 246205 Turku
Hungary Investigational Site Number 348205 Balassagyarmat
Hungary Investigational Site Number 348201 Budapest
Hungary Investigational Site Number 348207 Budapest
Hungary Investigational Site Number 348210 Budapest
Hungary Investigational Site Number 348212 Budapest
Hungary Investigational Site Number 348202 Urhida
Japan Investigational Site Number 392214 Fujimi
Japan Investigational Site Number 392215 Fujimi
Japan Investigational Site Number 392206 Ise-Shi
Japan Investigational Site Number 392217 Kitaazumi-Gun
Japan Investigational Site Number 392210 Matsumoto-Shi
Japan Investigational Site Number 392208 Matumoto
Japan Investigational Site Number 392205 Midori-Shi
Japan Investigational Site Number 392203 Mito-Shi
Japan Investigational Site Number 392216 Sakai
Japan Investigational Site Number 392213 Shimotsuke
Japan Investigational Site Number 392218 Shunan-Shi
Japan Investigational Site Number 392204 Yamagata-Shi
Latvia Investigational Site Number 428203 Riga
Latvia Investigational Site Number 428205 Riga
Latvia Investigational Site Number 428206 Riga
Latvia Investigational Site Number 428202 Sigulda
Latvia Investigational Site Number 428201 Ventspils
Lithuania Investigational Site Number 440203 Kaunas
Lithuania Investigational Site Number 440204 Kaunas
Lithuania Investigational Site Number 440201 Klaipeda
Lithuania Investigational Site Number 440202 Klaipeda
Lithuania Investigational Site Number 440205 Vilnius
Netherlands Investigational Site Number 528204 Almere
Netherlands Investigational Site Number 528209 Beek
Netherlands Investigational Site Number 528205 Breda
Netherlands Investigational Site Number 528207 Leiderdorp
Netherlands Investigational Site Number 528203 Rotterdam
Netherlands Investigational Site Number 528202 Velp
Puerto Rico Investigational Site Number 840709 Cagua
Puerto Rico Investigational Site Number 840706 Carolina
Puerto Rico Investigational Site Number 840703 San Juan
Puerto Rico Investigational Site Number 840704 San Juan
Puerto Rico Investigational Site Number 840708 San Juan
Puerto Rico Investigational Site Number 840710 San Juan
Romania Investigational Site Number 642208 Bacau
Romania Investigational Site Number 642201 Bucuresti
Romania Investigational Site Number 642212 Bucuresti
Romania Investigational Site Number 642202 Cluj-Napoca
Romania Investigational Site Number 642213 Oradea
Romania Investigational Site Number 642207 Resita
Romania Investigational Site Number 642205 Sibiu
Romania Investigational Site Number 642203 Targu Mures
Romania Investigational Site Number 642204 Targu Mures
Romania Investigational Site Number 642206 Timisoara
Romania Investigational Site Number 642209 Timisoara
Slovakia Investigational Site Number 703205 Banska Bystrica
Slovakia Investigational Site Number 703202 Bardejov
Slovakia Investigational Site Number 703203 Bratislava
Slovakia Investigational Site Number 703201 Levice
Slovakia Investigational Site Number 703206 Levice
Slovakia Investigational Site Number 703207 Lucenec
Sweden Investigational Site Number 752205 Kristianstad
Sweden Investigational Site Number 752206 Malmö
Sweden Investigational Site Number 752201 Stockholm
Sweden Investigational Site Number 752204 Vällingby
United States Investigational Site Number 840269 Albuquerque New Mexico
United States Investigational Site Number 840247 Asheville North Carolina
United States Investigational Site Number 840245 Atlanta Georgia
United States Investigational Site Number 840314 Avon Indiana
United States Investigational Site Number 840317 Avon Indiana
United States Investigational Site Number 840208 Baltimore Maryland
United States Investigational Site Number 840347 Bell Gardens California
United States Investigational Site Number 840219 Bend Oregon
United States Investigational Site Number 840299 Boca Raton Florida
United States Investigational Site Number 840285 Boynton Beach Florida
United States Investigational Site Number 840221 Bradenton Florida
United States Investigational Site Number 840260 Bristol Tennessee
United States Investigational Site Number 840239 Burke Virginia
United States Investigational Site Number 840273 Chandler Arizona
United States Investigational Site Number 840262 Chattanooga Tennessee
United States Investigational Site Number 840278 Chicago Illinois
United States Investigational Site Number 840320 Chicago Illinois
United States Investigational Site Number 840233 Clearwater Florida
United States Investigational Site Number 840330 Cleveland Ohio
United States Investigational Site Number 840249 Colorado Springs Colorado
United States Investigational Site Number 840307 Columbus Ohio
United States Investigational Site Number 840212 Coral Gables Florida
United States Investigational Site Number 840266 Coral Gables Florida
United States Investigational Site Number 840342 Corpus Christi Texas
United States Investigational Site Number 840294 Dakota Dunes South Dakota
United States Investigational Site Number 840242 Dallas Texas
United States Investigational Site Number 840268 Dallas Texas
United States Investigational Site Number 840292 Dallas Texas
United States Investigational Site Number 840315 Dallas Texas
United States Investigational Site Number 840331 Denver Colorado
United States Investigational Site Number 840214 Des Moines Iowa
United States Investigational Site Number 840326 Edinburg Texas
United States Investigational Site Number 840244 Escondido California
United States Investigational Site Number 840289 Fall River Massachusetts
United States Investigational Site Number 840257 Fresno California
United States Investigational Site Number 840213 Greenbrae California
United States Investigational Site Number 840296 Greensboro North Carolina
United States Investigational Site Number 840252 Greer South Carolina
United States Investigational Site Number 840306 Hamilton New Jersey
United States Investigational Site Number 840253 Haverhill Massachusetts
United States Investigational Site Number 840204 Hialeah Florida
United States Investigational Site Number 840248 Hollywood Florida
United States Investigational Site Number 840236 Honolulu Hawaii
United States Investigational Site Number 840218 Houston Texas
United States Investigational Site Number 840259 Houston Texas
United States Investigational Site Number 840328 Houston Texas
United States Investigational Site Number 840338 Houston Texas
United States Investigational Site Number 840267 Huntington Beach California
United States Investigational Site Number 840283 Idaho Falls Idaho
United States Investigational Site Number 840224 Jacksonville Florida
United States Investigational Site Number 840226 Jacksonville Florida
United States Investigational Site Number 840318 Jacksonville Florida
United States Investigational Site Number 840230 La Jolla California
United States Investigational Site Number 840235 La Mesa California
United States Investigational Site Number 840274 La Mesa California
United States Investigational Site Number 840201 Las Vegas Nevada
United States Investigational Site Number 840256 Las Vegas Nevada
United States Investigational Site Number 840349 Las Vegas Nevada
United States Investigational Site Number 840344 Lexington Kentucky
United States Investigational Site Number 840304 Little Rock Arkansas
United States Investigational Site Number 840222 Long Beach California
United States Investigational Site Number 840270 Madison Heights Michigan
United States Investigational Site Number 840206 Manassas Virginia
United States Investigational Site Number 840217 Mesa Arizona
United States Investigational Site Number 840348 Metairie Louisiana
United States Investigational Site Number 840228 Miami Florida
United States Investigational Site Number 840238 Miami Florida
United States Investigational Site Number 840302 Miami Florida
United States Investigational Site Number 840337 Miami Beach Florida
United States Investigational Site Number 840311 Milwaukee Wisconsin
United States Investigational Site Number 840324 Montgomery Alabama
United States Investigational Site Number 840275 Morganton North Carolina
United States Investigational Site Number 840202 Murray Utah
United States Investigational Site Number 840231 Murray Kentucky
United States Investigational Site Number 840310 New Hyde Park New York
United States Investigational Site Number 840290 New Orleans Louisiana
United States Investigational Site Number 840227 New Port Richey Florida
United States Investigational Site Number 840229 Norman Oklahoma
United States Investigational Site Number 840303 North Miami Beach Florida
United States Investigational Site Number 840225 Ocala Florida
United States Investigational Site Number 840210 Omaha Nebraska
United States Investigational Site Number 840263 Omaha Nebraska
United States Investigational Site Number 840300 Omaha Nebraska
United States Investigational Site Number 840291 Orlando Florida
United States Investigational Site Number 840316 Orlando Florida
United States Investigational Site Number 840232 Overland Park Kansas
United States Investigational Site Number 840216 Oviedo Florida
United States Investigational Site Number 840332 Palm Harbor Florida
United States Investigational Site Number 840243 Palm Springs California
United States Investigational Site Number 840327 Pearland Texas
United States Investigational Site Number 840288 Pembroke Pines Florida
United States Investigational Site Number 840220 Peoria Arizona
United States Investigational Site Number 840240 Philadelphia Pennsylvania
United States Investigational Site Number 840207 Phoenix Arizona
United States Investigational Site Number 840211 Phoenix Arizona
United States Investigational Site Number 840325 Port Charlotte Florida
United States Investigational Site Number 840246 Renton Washington
United States Investigational Site Number 840301 Rockville Maryland
United States Investigational Site Number 840343 Salt Lake City Utah
United States Investigational Site Number 840282 San Antonio Texas
United States Investigational Site Number 840203 Sea Girt New Jersey
United States Investigational Site Number 840295 Sicklerville New Jersey
United States Investigational Site Number 840237 Spartanburg South Carolina
United States Investigational Site Number 840250 Spring Valley California
United States Investigational Site Number 840276 Springfield Illinois
United States Investigational Site Number 840309 St. Petersburg Florida
United States Investigational Site Number 840323 Stockbridge Georgia
United States Investigational Site Number 840251 Tampa Florida
United States Investigational Site Number 840209 Temecula California
United States Investigational Site Number 840234 Tempe Arizona
United States Investigational Site Number 840264 Tempe Arizona
United States Investigational Site Number 840308 Tipton Pennsylvania
United States Investigational Site Number 840287 Topeka Kansas
United States Investigational Site Number 840297 Torrance California
United States Investigational Site Number 840272 Tustin California
United States Investigational Site Number 840223 Walnut Creek California
United States Investigational Site Number 840339 West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czech Republic,  Denmark,  Estonia,  Finland,  Hungary,  Japan,  Latvia,  Lithuania,  Netherlands,  Puerto Rico,  Romania,  Slovakia,  Sweden, 

References & Publications (1)

Bolli GB, Riddle MC, Bergenstal RM, Ziemen M, Sestakauskas K, Goyeau H, Home PD; on behalf of the EDITION 3 study investigators. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-low — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HbA1c From Baseline to Month 6 Endpoint Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. Baseline, Month 6 No
Secondary Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively. Week 9 Up to Month 6 No
Secondary Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. Baseline, Month 6 No
Secondary Variability of Preinjection SMPG at Month 6 Endpoint Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. Month 6 No
Secondary Percentage of Participants With HbA1c <7% at Month 6 Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit. Month 6 No
Secondary Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. Baseline, Month 6 No
Secondary Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6 Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit. Month 6 No
Secondary Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit. Baseline, Month 6 No
Secondary Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. Baseline, Month 6 No
Secondary Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. Baseline, Month 6 No
Secondary Change in Daily Basal Insulin Dose From Baseline to Month 6 Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit. Baseline, Month 6 No
Secondary Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows. Baseline, Month 6 No
Secondary Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L). Up to 12 months Yes
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