Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

239

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

September 30, 2009

Study Completion Date

September 30, 2009

Conditions
Diabetes
Interventions
DRUG

placebo

placebo capsule,0 units, quater in die (QID) for 18 weeks

DRUG

Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)

Oral HDV-I Caps; 15 U; quater in die (QID) for 18 weeks.

DRUG

Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)

Oral HDV-I; Caps; 5 U; quater in die (QID) for 18 weeks.

Trial Locations (40)

10301

Staten Island

15009

Beaver

20110

Manassas

23454

Virginia Beach

30308

Atlanta

30322

Atlanta

32626

Chiefland

33029

Pembroke Pines

33308

Fort Lauderdale

34684

Palm Harbor

35661

Muscle Shoals

37660

Kingsport

39466

Picayune

40504

Lexington

42003

Paducah

43015

Delaware

43701

Zanesville

45236

Cincinnati

53209

Milwaukee

66606

Topeka

68114

Omaha

76054

Hurst

77074

Houston

78229

San Antonio

78237

San Antonio

78404

Corpus Christi

79761

Odessa

79935

El Paso

84124

Salt Lake City

85340

Litchfield Park

85712

Tucson

90723

Paramount

91607

Valley Village

94401

San Mateo

94520

Concord

94598

Walnut Creek

95204

Stockton

95825

Sacramento

98055

Renton

02301

Brockton

Sponsors
All Listed Sponsors
lead

Diasome Pharmaceuticals

INDUSTRY