A Phase 3, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 3, Open-label, Long-term Study of SYR-472 (100 mg) in Combination With Insulin in Patients With Type 2 Diabetes



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:20 - Any
Updated:1/2/2016
Start Date:December 2014
End Date:December 2016
Contact:Takeda Study Registration Call Center
Email:medicalinformation@tpna.com
Phone:+1-800-778-2860

Use our guide to learn which trials are right for you!

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Comparative Study and a Phase 3, Multicenter, Open-label, Long-term Study to Evaluate the Safety and Efficacy of SYR-472 When Orally Administered at a Dose of 100 mg Once Weekly as an add-on to Insulin Therapy in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Treatment With Insulin Preparations in Addition to Diet and/or Exercise Therapy

The purpose of this study is to evaluate the efficacy and safety of SYR-472 when
administered at a dose of 100 mg once weekly as an add-on to insulin therapy (SYR-472 100 mg
combination/SYR-472 100 mg combination group) using insulin preparation alone/ SYR-472 100
mg combination group as a control in patients with type 2 diabetes mellitus and inadequate
glycemic control despite treatment with insulin preparations in addition to diet and/or
exercise therapy; and to evaluate the long-term efficacy and safety of SYR-472 when
administered at a dose of 100 mg once weekly as an add-on to insulin therapy in patients
with type 2 diabetes mellitus and inadequate glycemic control despite treatment with insulin
preparations in addition to diet and/or exercise therapy.

This is a phase 3, multicenter, randomized, double-blind, parallel-group, comparative study
using insulin preparation alone/SYR-472 100 mg combination group as a control (Treatment
Period I) and a phase 3, multicenter, open-label, long-term study (Treatment Period II) to
evaluate the efficacy and safety of SYR-472 when administered at a dose of 100 mg as an
add-on to insulin therapy (SYR-472 100 mg combination/SYR-472 100 mg combination group) in
patients with type 2 diabetes mellitus and inadequate glycemic control despite treatment
with insulin preparations in addition to diet and/or exercise therapy.

Inclusion Criteria:

Participant eligibility is determined according to the following criteria:

1. The participant has a diagnosis of type 2 diabetes mellitus.

2. The participant has a fasting C-peptide level of 0.6 ng/mL or higher at the start of
the screening period (Week -6) and Week -2 of the screening period.

3. The participant has an HbA1c value of 7.5% or higher but less than 10.0% at Week -2
of the screening period.

4. The participant has an HbA1c value difference between the start of the screening
period (Week -6) and Week -2 of the screening period within 10.0%* (* rounded to one
decimal place) of the HbA1c value at the start of the screening period (Week -6).

5. The participant has been on a fixed diet and/or exercise therapy (if any) from at
least 6 weeks prior to the start of the screening period (Week -6).

6. The participant is being treated with insulin preparations alone (≥8 units/day and
≤40 units/day) ** from at least 6 weeks prior to the start of the screening period
(Week -6) at a fixed dose and regimen of the insulin preparation.

- The participant on any one of the following insulin monotherapies: mixed
(rapid-acting or short-acting insulin containing no more than 30% volume),
intermediate-acting, or long-acting soluble insulin preparations

7. The participant is deemed appropriate for treatment with a combination of insulin and
another antidiabetic drug at the start of the screening period (Week -6) by the
investigator or subinvestigator.

8. The participants with controlled and stable blood pressure will not need any change
in the dose of antihypertensive drugs (including discontinuation and suspension) or
additional antihypertensive drugs during the study period as assessed by the
investigator or subinvestigator.

9. The participant is male or female and aged 20 years or older at the time of informed
consent.

10. A female participant of childbearing potential who is sexually active with a
nonsterilized male partner agrees to use routinely adequate contraception from
signing of informed consent until one month after the end of the study.

11. In the opinion of the investigator or subinvestigator, the participant is capable of
understanding and complying with protocol requirements.

12. The participant signs and dates a written, informed consent form prior to the
initiation of any study procedures.

Exclusion Criteria:

Any participant who meets any of the following criteria will not qualify for entry into
the study:

1. The participants has clinical manifestations of hepatic impairment [e.g., AST or ALT
≥2.5 times the upper limit of normal or total bilirubin of ≥2.0 mg/dL at the start of
the screening period (Week -6) or at Week -2 of the screening period].

2. The participant has moderate or severe renal impairment or end-stage renal failure
[e.g., creatinine clearance (Ccr) <50 mL/min at the start of the screening period
(Week -6) or Week -2 of the screening period].

3. The participant has any serious cardiac diseases, cerebrovascular disorders, or
serious pancreatic or hematological diseases (e.g., participants who require
inpatient treatment or are hospitalized for treatment within 24 weeks prior to the
start of the screening period).

4. The participant has, in the judgment of the investigator or subinvestigator,
clinically significant abnormal hematological parameters of hemoglobin, hematocrit,
or erythrocytes at the start of the screening period (Week - 6) or Week -2 of the
screening period.

5. The participant has a systolic blood pressure of 180 mmHg or higher or a diastolic
blood pressure of 110 mmHg or higher during the screening period.

6. The participant is on at least two antidiabetic therapies other than one insulin
preparation one day before 6 weeks prior to the start of the screening period (Week
-6) (43 days prior to the start of the screening period).

7. The participants altered the dose and regimen of their insulin preparation within 6
weeks prior to the start of the screening period or during the screening period.

8. The participant experienced hypoglycemia (participants with a blood glucose level of
≤70 mg/dL or hypoglycemic symptoms) within 6 weeks prior to the start of the
screening period or during the screening period (at least twice per week).

9. The participant has a fasting blood glucose level of 240 mg/dL or higher at the start
of the screening period (Week -6) or at Week -2 of the screening period.

10. The participant has malignancies.

11. The participant has a history of hypersensitivity or allergies to dipeptidyl
peptidase 4 (DPP-4) inhibitors or insulin preparations.

12. The participant has a history of gastrectomy or small intestinal resection.

13. The participant is habitual drinker consuming a daily average of more than 100 mL of
alcohol.

14. The participant has a history of drug abuse (defined as the use of an illegal drug)
or alcohol dependence.

15. The participant is required to take excluded medications during the study period.

16. The participant has received SYR-472 in a previous clinical study.

17. The participant is deemed to be in a condition contraindicating treatment as
specified in the package insert of insulin preparations by the investigator or
subinvestigator.

18. The participant received any investigational products (including study drugs in a
post-marketing clinical study) within 12 weeks prior to the start of the screening
period.

19. The participant is participating in other clinical studies at the time of informed
consent.

20. If female, the participant is pregnant or lactating or intending to become pregnant
before, during, or within 1 month after participating in this study; or intending to
donate ova during such time period.

21. The participant is immediate family member, study site employee, or is in a dependant
relationship with a study site employee who is involved in conduct of this study (eg,
spouse, parent, child, sibling) or may consent under duress.

22. The participant is hospitalized during the screening period or deemed as requiring
hospitalization during the study period by the investigator or subinvestigator,
unless the hospitalization is for short-term evaluations including complete health
checkups.

23. The participant is deemed to be ineligible for the study for any other reason by the
investigator or subinvestigator.
We found this trial at
86
sites
1225
mi
from
Philadelphia, PA
Click here to add this to my saved trials
523
mi
from
Albuquerque, NM
Click here to add this to my saved trials
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
522
mi
from
Austin, TX
Click here to add this to my saved trials
571
mi
from
Bellaire, TX
Click here to add this to my saved trials
1165
mi
from
Bellflower, CA
Click here to add this to my saved trials
683
mi
from
Birmingham, AL
Click here to add this to my saved trials
780
mi
from
Bountiful, UT
Click here to add this to my saved trials
631
mi
from
Brownsburg, IN
Click here to add this to my saved trials
610
mi
from
Chicago, IL
Click here to add this to my saved trials
Clarksburg, West Virginia 26301
949
mi
from
Clarksburg, WV
Click here to add this to my saved trials
582
mi
from
Clarksville, TN
Click here to add this to my saved trials
1102
mi
from
Clearwater, FL
Click here to add this to my saved trials
972
mi
from
Columbia, SC
Click here to add this to my saved trials
1048
mi
from
Columbiana, NC
Click here to add this to my saved trials
1319
mi
from
Coral Gables, FL
Click here to add this to my saved trials
1295
mi
from
Coral Springs, FL
Click here to add this to my saved trials
688
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
841
mi
from
Detroit, MI
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
1052
mi
from
Duncansville, PA
Click here to add this to my saved trials
799
mi
from
Dunwoody, GA
Click here to add this to my saved trials
800
mi
from
East Point, GA
Click here to add this to my saved trials
1145
mi
from
Edgewater, FL
Click here to add this to my saved trials
652
mi
from
Elizabethtown, KY
Click here to add this to my saved trials
Fall River, Massachusetts 02720
1437
mi
from
Fall River, MA
Click here to add this to my saved trials
635
mi
from
Fargo, ND
Click here to add this to my saved trials
420 West 12th Avenue
Franklin, Ohio 43210
810
mi
from
Franklin, OH
Click here to add this to my saved trials
Greensboro, North Carolina 27401
1002
mi
from
Greensboro, NC
Click here to add this to my saved trials
889
mi
from
Greer, SC
Click here to add this to my saved trials
612
mi
from
Gurnee, IL
Click here to add this to my saved trials
1177
mi
from
Harbor City, CA
Click here to add this to my saved trials
1213
mi
from
Harleysville, PA
Click here to add this to my saved trials
410
mi
from
Hazelwood, MO
Click here to add this to my saved trials
1314
mi
from
Hialeah, FL
Click here to add this to my saved trials
3718
mi
from
Honolulu, HI
Click here to add this to my saved trials
Huntington Park, California 90255
1169
mi
from
Huntington Park, CA
Click here to add this to my saved trials
Indian Land, South Carolina 29707
961
mi
from
Indian Land, SC
Click here to add this to my saved trials
1152
mi
from
Irvine, CA
Click here to add this to my saved trials
721
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
779
mi
from
Knoxville, TN
Click here to add this to my saved trials
971
mi
from
Las Vegas, NV
Click here to add this to my saved trials
725
mi
from
Lexington, KY
Click here to add this to my saved trials
372
mi
from
Little Rock, AR
Click here to add this to my saved trials
1178
mi
from
Lomita, CA
Click here to add this to my saved trials
1171
mi
from
Long Beach, CA
Click here to add this to my saved trials
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
674
mi
from
Mandeville, LA
Click here to add this to my saved trials
119
mi
from
Manhattan, KS
Click here to add this to my saved trials
966
mi
from
McMurray, PA
Click here to add this to my saved trials
1212
mi
from
Media, PA
Click here to add this to my saved trials
467
mi
from
Memphis, TN
Click here to add this to my saved trials
690
mi
from
Metairie, LA
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
1323
mi
from
Miami Beach, FL
Click here to add this to my saved trials
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
1124
mi
from
Murrieta, CA
Click here to add this to my saved trials
604
mi
from
Muscle Shoals, AL
Click here to add this to my saved trials
587
mi
from
Nassau Bay, TX
Click here to add this to my saved trials
1170
mi
from
Newport News, VA
Click here to add this to my saved trials
1181
mi
from
Norfolk, VA
Click here to add this to my saved trials
158
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
1154
mi
from
Orange, CA
Click here to add this to my saved trials
1139
mi
from
Orlando, FL
Click here to add this to my saved trials
508
mi
from
Paducah, KY
Click here to add this to my saved trials
1302
mi
from
Pembroke Pines, FL
Click here to add this to my saved trials
853
mi
from
Phoenix, AZ
Click here to add this to my saved trials
971
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
332
mi
from
Plano, TX
Click here to add this to my saved trials
1304
mi
from
Plantation, FL
Click here to add this to my saved trials
1177
mi
from
Port Charlotte, FL
Click here to add this to my saved trials
1383
mi
from
Portland, OR
Click here to add this to my saved trials
Rancho Cucamonga, California 91730
1131
mi
from
Rancho Cucamonga, CA
Click here to add this to my saved trials
Redondo Beach, California 90277
1181
mi
from
Redondo Beach, CA
Click here to add this to my saved trials
1111
mi
from
Richmond, VA
Click here to add this to my saved trials
1278
mi
from
Sacramento, CA
Click here to add this to my saved trials
1158
mi
from
Saint Cloud, FL
Click here to add this to my saved trials
Salisbury, North Carolina 28144
970
mi
from
Salisbury, NC
Click here to add this to my saved trials
583
mi
from
San Antonio, TX
Click here to add this to my saved trials
1319
mi
from
San Jose, CA
Click here to add this to my saved trials
1315
mi
from
San Ramon, CA
Click here to add this to my saved trials
809
mi
from
Suwanee, GA
Click here to add this to my saved trials
1227
mi
from
Vero Beach, FL
Click here to add this to my saved trials
1196
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
374
mi
from
Washington, MO
Click here to add this to my saved trials
27
mi
from
Wichita, KS
Click here to add this to my saved trials
Wilmington, North Carolina 28401
1135
mi
from
Wilmington, NC
Click here to add this to my saved trials