BEGIN™: Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01068678
Collaborator
(none)
460
99
2
9
4.6
0.5
Study Details
Study Description
Brief Summary
This trial is conducted in Africa, Asia, Europe, and North America. The aim of this clinical trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes currently treated with metformin alone or with metformin combined with an oral anti-diabetic drug (OAD) qualifying for intensified treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
460 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: EASY AM)
Study Start Date
:
Feb 1, 2010
Actual Primary Completion Date
:
Nov 1, 2010
Actual Study Completion Date
:
Nov 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IDeg 3 times weekly (3TW)
|
Drug: insulin degludec
Injected subcutaneously (under the skin) three times weekly. Dose was individually adjusted.
|
| Active Comparator: IGlar OD
|
Drug: insulin glargine
Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
|
Outcome Measures
Primary Outcome Measures
- Change in Glycosylated Haemoglobin (HbA1c) [Week 26]
Change from baseline in HbA1c after week 26
Secondary Outcome Measures
- Change in Body Weight [Week 26]
Change from baseline in body weight after week 26
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Insulin naïve subject (allowed are: previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
-
Current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least three months prior to Visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily) -Insulin secretaguogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
-
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
-
Body Mass Index (BMI) below or equal to 45.0 kg/m^2
Exclusion Criteria:
-
Use within the last 3 months prior to Visit 1 of: thiazoledinediones, exenatide or liraglutide
-
Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
-
Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
-
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for UK: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods)
-
Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Northridge | California | United States | 91325 |
| 2 | Novo Nordisk Investigational Site | Palm Springs | California | United States | 92262 |
| 3 | Novo Nordisk Investigational Site | Paramount | California | United States | 90723 |
| 4 | Novo Nordisk Investigational Site | Santa Ana | California | United States | 92704 |
| 5 | Novo Nordisk Investigational Site | Spring Valley | California | United States | 91978 |
| 6 | Novo Nordisk Investigational Site | Tustin | California | United States | 92780 |
| 7 | Novo Nordisk Investigational Site | Melbourne | Florida | United States | 32901 |
| 8 | Novo Nordisk Investigational Site | Atlanta | Georgia | United States | 30318 |
| 9 | Novo Nordisk Investigational Site | Columbus | Georgia | United States | 31909 |
| 10 | Novo Nordisk Investigational Site | Perry | Georgia | United States | 31069 |
| 11 | Novo Nordisk Investigational Site | Olympia Fields | Illinois | United States | 60461 |
| 12 | Novo Nordisk Investigational Site | Avon | Indiana | United States | 46123 |
| 13 | Novo Nordisk Investigational Site | Fishers | Indiana | United States | 46038-1862 |
| 14 | Novo Nordisk Investigational Site | Franklin | Indiana | United States | 46131-9121 |
| 15 | Novo Nordisk Investigational Site | Indianapolis | Indiana | United States | 46254 |
| 16 | Novo Nordisk Investigational Site | Muncie | Indiana | United States | 47304 |
| 17 | Novo Nordisk Investigational Site | Des Moines | Iowa | United States | 50314 |
| 18 | Novo Nordisk Investigational Site | Lexington | Kentucky | United States | 40503 |
| 19 | Novo Nordisk Investigational Site | Paducah | Kentucky | United States | 42003 |
| 20 | Novo Nordisk Investigational Site | Hyattsville | Maryland | United States | 20782 |
| 21 | Novo Nordisk Investigational Site | Rockville | Maryland | United States | 20852 |
| 22 | Novo Nordisk Investigational Site | Interlochen | Michigan | United States | 49643 |
| 23 | Novo Nordisk Investigational Site | Jackson | Mississippi | United States | 39216 |
| 24 | Novo Nordisk Investigational Site | Chesterfield | Missouri | United States | 63017 |
| 25 | Novo Nordisk Investigational Site | St. Peters | Missouri | United States | 63376 |
| 26 | Novo Nordisk Investigational Site | Billings | Montana | United States | 59101 |
| 27 | Novo Nordisk Investigational Site | Lincoln | Nebraska | United States | 68521 |
| 28 | Novo Nordisk Investigational Site | Hamilton | New Jersey | United States | 08619 |
| 29 | Novo Nordisk Investigational Site | Toms River | New Jersey | United States | 08755-8050 |
| 30 | Novo Nordisk Investigational Site | Syracuse | New York | United States | 13210 |
| 31 | Novo Nordisk Investigational Site | West Seneca | New York | United States | 14224 |
| 32 | Novo Nordisk Investigational Site | Durham | North Carolina | United States | 27710 |
| 33 | Novo Nordisk Investigational Site | Winston Salem | North Carolina | United States | 27103 |
| 34 | Novo Nordisk Investigational Site | Canton | Ohio | United States | 44718 |
| 35 | Novo Nordisk Investigational Site | Cleveland | Ohio | United States | 44115 |
| 36 | Novo Nordisk Investigational Site | Dayton | Ohio | United States | 45439 |
| 37 | Novo Nordisk Investigational Site | Mentor | Ohio | United States | 44060 |
| 38 | Novo Nordisk Investigational Site | Pottstown | Pennsylvania | United States | 19464 |
| 39 | Novo Nordisk Investigational Site | Upper St.Clair | Pennsylvania | United States | 15241 |
| 40 | Novo Nordisk Investigational Site | Charleston | South Carolina | United States | 29455 |
| 41 | Novo Nordisk Investigational Site | Greer | South Carolina | United States | 29651 |
| 42 | Novo Nordisk Investigational Site | Simpsonville | South Carolina | United States | 29681 |
| 43 | Novo Nordisk Investigational Site | Nashville | Tennessee | United States | 37203 |
| 44 | Novo Nordisk Investigational Site | Amarillo | Texas | United States | 79106 |
| 45 | Novo Nordisk Investigational Site | Arlington | Texas | United States | 76014-2010 |
| 46 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75231 |
| 47 | Novo Nordisk Investigational Site | Fort Worth | Texas | United States | 76113 |
| 48 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77074 |
| 49 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77095 |
| 50 | Novo Nordisk Investigational Site | Irving | Texas | United States | 75061-2210 |
| 51 | Novo Nordisk Investigational Site | Plano | Texas | United States | 75024 |
| 52 | Novo Nordisk Investigational Site | San Antonio | Texas | United States | 78224 |
| 53 | Novo Nordisk Investigational Site | Salt Lake City | Utah | United States | 84107 |
| 54 | Novo Nordisk Investigational Site | Fredericksburg | Virginia | United States | 22408-2674 |
| 55 | Novo Nordisk Investigational Site | Richmond | Virginia | United States | 23225-4017 |
| 56 | Novo Nordisk Investigational Site | Virginia Beach | Virginia | United States | 23462 |
| 57 | Novo Nordisk Investigational Site | Menomonee Falls | Wisconsin | United States | 53051-4049 |
| 58 | Novo Nordisk Investigational Site | Calgary | Alberta | Canada | T3C 3P1 |
| 59 | Novo Nordisk Investigational Site | Edmonton | Alberta | Canada | T5J 3N4 |
| 60 | Novo Nordisk Investigational Site | Winnipeg | Manitoba | Canada | R3E 3P4 |
| 61 | Novo Nordisk Investigational Site | St. John's | Newfoundland and Labrador | Canada | A1A 3R5 |
| 62 | Novo Nordisk Investigational Site | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 63 | Novo Nordisk Investigational Site | London | Ontario | Canada | N6A 4V2 |
| 64 | Novo Nordisk Investigational Site | Mississauga | Ontario | Canada | L5M 2V8 |
| 65 | Novo Nordisk Investigational Site | Sarnia | Ontario | Canada | N7T 4X3 |
| 66 | Novo Nordisk Investigational Site | Sudbury | Ontario | Canada | P3E 1Y8 |
| 67 | Novo Nordisk Investigational Site | Toronto | Ontario | Canada | M3J 1N2 |
| 68 | Novo Nordisk Investigational Site | Toronto | Ontario | Canada | M4N 3M5 |
| 69 | Novo Nordisk Investigational Site | Toronto | Ontario | Canada | M4P 1P2 |
| 70 | Novo Nordisk Investigational Site | Mirabel | Quebec | Canada | J7J 2K8 |
| 71 | Novo Nordisk Investigational Site | Sherbrooke | Quebec | Canada | J1G 5K2 |
| 72 | Novo Nordisk Investigational Site | St John's | Canada | A1B 3V6 | |
| 73 | Novo Nordisk Investigational Site | Brandys nad Labem | Czech Republic | 250 01 | |
| 74 | Novo Nordisk Investigational Site | Mlada Boleslav | Czech Republic | 293 50 | |
| 75 | Novo Nordisk Investigational Site | Ostrava | Czech Republic | 707 02 | |
| 76 | Novo Nordisk Investigational Site | Prague | Czech Republic | 120 00 | |
| 77 | Novo Nordisk Investigational Site | Trutnov | Czech Republic | 541 01 | |
| 78 | Novo Nordisk Investigational Site | Petah-Tikva | Israel | 49372 | |
| 79 | Novo Nordisk Investigational Site | Rehovot | Israel | 76100 | |
| 80 | Novo Nordisk Investigational Site | Rishon Le Zion | Israel | 75650 | |
| 81 | Novo Nordisk Investigational Site | Tel Hashomer | Israel | 52621 | |
| 82 | Novo Nordisk Investigational Site | Zefat | Israel | 13100 | |
| 83 | Novo Nordisk Investigational Site | Manati | Puerto Rico | 00674 | |
| 84 | Novo Nordisk Investigational Site | Bratislava | Slovakia | 811 08 | |
| 85 | Novo Nordisk Investigational Site | Kosice | Slovakia | 04-001 | |
| 86 | Novo Nordisk Investigational Site | Moldava nad Bodvou | Slovakia | 045 01 | |
| 87 | Novo Nordisk Investigational Site | Nove Zamky | Slovakia | 940 59 | |
| 88 | Novo Nordisk Investigational Site | Presov | Slovakia | 080 01 | |
| 89 | Novo Nordisk Investigational Site | Johannesburg | Gauteng | South Africa | 2198 |
| 90 | Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | South Africa | 4091 |
| 91 | Novo Nordisk Investigational Site | Aberdeen | United Kingdom | AB25 1LD | |
| 92 | Novo Nordisk Investigational Site | Aldershot | United Kingdom | GU12 5BA | |
| 93 | Novo Nordisk Investigational Site | Birmingham | United Kingdom | B9 5SS | |
| 94 | Novo Nordisk Investigational Site | Chippenham | United Kingdom | SN15 2SB | |
| 95 | Novo Nordisk Investigational Site | Exeter | United Kingdom | EX2 5AX | |
| 96 | Novo Nordisk Investigational Site | Guildford | United Kingdom | GU2 7XX | |
| 97 | Novo Nordisk Investigational Site | Nuneaton | United Kingdom | CV10 7DJ | |
| 98 | Novo Nordisk Investigational Site | Portsmouth | United Kingdom | PO6 3LY | |
| 99 | Novo Nordisk Investigational Site | Watford | United Kingdom | WD18 0HB |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01068678
Other Study ID Numbers:
- NN1250-3724
- 2009-011398-33
- U1111-1113-2412
First Posted:
Feb 15, 2010
Last Update Posted:
Mar 6, 2017
Last Verified:
Jan 1, 2017
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The trial was conducted at 94 sites in 7 countries: Canada (14 sites), Czech Republic (5 sites), Israel (5 sites), Slovakia (5 sites), South Africa (3 sites), United Kingdom (8 sites) and United States (54 sites). In addition, 9 sites (United Kingdom (1 site) and United States (8 sites)) were approved, but did not enroll any subjects. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | IDeg 3TW | IGlar OD |
|---|---|---|
| Arm/Group Description | Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks. | Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks. |
| Period Title: Overall Study | ||
| STARTED | 230 | 230 |
| Exposed | 227 | 229 |
| COMPLETED | 192 | 206 |
| NOT COMPLETED | 38 | 24 |
Baseline Characteristics
| Arm/Group Title | IDeg 3TW | IGlar OD | Total |
|---|---|---|---|
| Arm/Group Description | Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks. | Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks. | Total of all reporting groups |
| Overall Participants | 229 | 230 | 459 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
58.4
(9.9)
|
57.9
(9.7)
|
58.1
(9.8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
105
45.9%
|
93
40.4%
|
198
43.1%
|
| Male |
124
54.1%
|
137
59.6%
|
261
56.9%
|
| Glycosylated haemoglobin (HbA1c) (percentage of glycosylated haemoglobin) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [percentage of glycosylated haemoglobin] |
8.2
(0.8)
|
8.3
(0.9)
|
8.2
(0.8)
|
| Body weight (kg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg] |
90.8
(18.6)
|
95.7
(19.0)
|
93.3
(18.9)
|
| Fasting Plasma Glucose (mmol/L) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mmol/L] |
9.3
(2.4)
|
9.6
(2.4)
|
9.5
(2.4)
|
Outcome Measures
| Title | Change in Glycosylated Haemoglobin (HbA1c) |
|---|---|
| Description | Change from baseline in HbA1c after week 26 |
| Time Frame | Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full analysis set (FAS) included all randomised subjects and missing data is imputed using last observation carried forward (LOCF).1 subject was randomised despite being a screening failure. |
| Arm/Group Title | IDeg 3TW | IGlar OD |
|---|---|---|
| Arm/Group Description | Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks. | Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks. |
| Measure Participants | 229 | 230 |
| Mean (Standard Deviation) [percentage of glycosylated haemoglobin] |
-1.00
(0.95)
|
-1.40
(1.07)
|
| Title | Change in Body Weight |
|---|---|
| Description | Change from baseline in body weight after week 26 |
| Time Frame | Week 26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using last observation carried forward (LOCF). For 3 subjects baseline values were missing. |
| Arm/Group Title | IDeg 3TW | IGlar OD |
|---|---|---|
| Arm/Group Description | Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks. | Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks. |
| Measure Participants | 227 | 229 |
| Mean (Standard Deviation) [kg] |
0.8
(3.6)
|
1.0
(3.7)
|
Adverse Events
| Time Frame | Adverse events were collected in a time frame of 26 weeks + 7 days follow up | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The safety analysis set includes all subjects who received atleast one dose of investigational product or its comparator. 227 subjects in IDeg 3TW and 229 in IGLar OD were included in the analysis. | |||
| Arm/Group Title | IDeg 3TW | IGlar OD | ||
| Arm/Group Description | Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks. | Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks. | ||
All Cause Mortality |
||||
| IDeg 3TW | IGlar OD | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| IDeg 3TW | IGlar OD | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/227 (4.8%) | 4/229 (1.7%) | ||
| Cardiac disorders | ||||
| Angina unstable | 2/227 (0.9%) | 2 | 0/229 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 0/227 (0%) | 0 | 1/229 (0.4%) | 1 |
| General disorders | ||||
| Non-cardiac chest pain | 1/227 (0.4%) | 1 | 0/229 (0%) | 0 |
| Infections and infestations | ||||
| Appendicitis | 1/227 (0.4%) | 1 | 0/229 (0%) | 0 |
| Cellulitis | 1/227 (0.4%) | 1 | 0/229 (0%) | 0 |
| Diverticulitis | 0/227 (0%) | 0 | 1/229 (0.4%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 1/227 (0.4%) | 1 | 0/229 (0%) | 0 |
| Forearm fracture | 1/227 (0.4%) | 1 | 0/229 (0%) | 0 |
| Incisional hernia | 1/227 (0.4%) | 1 | 0/229 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Hypoglycaemia | 1/227 (0.4%) | 1 | 0/229 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Fibromyalgia | 0/227 (0%) | 0 | 1/229 (0.4%) | 1 |
| Osteoarthritis | 0/227 (0%) | 0 | 1/229 (0.4%) | 1 |
| Renal and urinary disorders | ||||
| Calculus bladder | 1/227 (0.4%) | 1 | 0/229 (0%) | 0 |
| Renal colic | 0/227 (0%) | 0 | 1/229 (0.4%) | 1 |
| Vascular disorders | ||||
| Peripheral arterial occlusive disease | 1/227 (0.4%) | 2 | 0/229 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| IDeg 3TW | IGlar OD | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 69/227 (30.4%) | 77/229 (33.6%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 16/227 (7%) | 17 | 17/229 (7.4%) | 20 |
| Nausea | 12/227 (5.3%) | 12 | 15/229 (6.6%) | 16 |
| General disorders | ||||
| Injection site haematoma | 11/227 (4.8%) | 15 | 12/229 (5.2%) | 12 |
| Infections and infestations | ||||
| Nasopharyngitis | 15/227 (6.6%) | 16 | 17/229 (7.4%) | 18 |
| Upper respiratory tract infection | 5/227 (2.2%) | 5 | 16/229 (7%) | 19 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 14/227 (6.2%) | 18 | 14/229 (6.1%) | 21 |
| Nervous system disorders | ||||
| Headache | 26/227 (11.5%) | 38 | 21/229 (9.2%) | 26 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
Results Point of Contact
| Name/Title | Public Access to Clinical Trials |
|---|---|
| Organization | Novo Nordisk A/S |
| Phone | |
| clinicaltrials@novonordisk.com |
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01068678
Other Study ID Numbers:
- NN1250-3724
- 2009-011398-33
- U1111-1113-2412
First Posted:
Feb 15, 2010
Last Update Posted:
Mar 6, 2017
Last Verified:
Jan 1, 2017