Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus (BEGIN™)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01326026 |
|
Recruitment Status :
Completed
First Posted : March 30, 2011
Results First Posted : November 17, 2015
Last Update Posted : March 6, 2017
|
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different self-titration algorithms (dose individually adjusted) in combination with metformin.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Diabetes Mellitus, Type 2 | Drug: insulin degludec | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 222 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Trial Comparing the Efficacy and Safety of Insulin Degludec Once Daily in Insulin naïve Subjects With Type 2 Diabetes Mellitus When Titrated Using Two Different Titration Algorithms (BEGIN™: ONCE SIMPLE USE) |
| Study Start Date : | March 2011 |
| Actual Primary Completion Date : | December 2011 |
| Actual Study Completion Date : | December 2011 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
| Arm | Intervention/treatment |
|---|---|
| Experimental: IDeg Simple |
Drug: insulin degludec
Injected subcutaneously (under the skin) once daily. Dose individually adjusted. |
| Experimental: IDeg Step wise |
Drug: insulin degludec
Injected subcutaneously (under the skin) once daily. Dose individually adjusted in a stepwise manner. |
Primary Outcome Measures :
- Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ]Change from baseline in HbA1c after 26 weeks of treatment.
Secondary Outcome Measures :
- Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, Week 26 ]Change from baseline in FPG after 26 weeks of treatment.
- Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 26 + 7 days follow up ]Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
- Rate of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ]Observed rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
- Rate of Nocturnal Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 26 + 7 days follow up ]Observed rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation (Visit 2)
- Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
- HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
- BMI (Body Mass Index) no higher than 45.0 kg/m^2
Exclusion Criteria:
- Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2
- Suffer from a life threatening disease (e.g. cancer)
- Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise [for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner])
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326026
Locations
| United States, Alabama | |
| Novo Nordisk Investigational Site | |
| Birmingham, Alabama, United States, 35216 | |
| Novo Nordisk Investigational Site | |
| Huntsville, Alabama, United States, 35801 | |
| United States, California | |
| Novo Nordisk Investigational Site | |
| Anaheim, California, United States, 92801 | |
| Novo Nordisk Investigational Site | |
| La Jolla, California, United States, 92037 | |
| Novo Nordisk Investigational Site | |
| Mission Hills, California, United States, 91345 | |
| Novo Nordisk Investigational Site | |
| National City, California, United States, 91950 | |
| Novo Nordisk Investigational Site | |
| North Hollywood, California, United States, 91606 | |
| Novo Nordisk Investigational Site | |
| San Diego, California, United States, 92111 | |
| United States, Colorado | |
| Novo Nordisk Investigational Site | |
| Golden, Colorado, United States, 80401 | |
| United States, Florida | |
| Novo Nordisk Investigational Site | |
| Kissimmee, Florida, United States, 34741 | |
| Novo Nordisk Investigational Site | |
| Tampa, Florida, United States, 33603 | |
| United States, Georgia | |
| Novo Nordisk Investigational Site | |
| Columbus, Georgia, United States, 31909 | |
| United States, Illinois | |
| Novo Nordisk Investigational Site | |
| Springfield, Illinois, United States, 62711 | |
| United States, Indiana | |
| Novo Nordisk Investigational Site | |
| Evansville, Indiana, United States, 47714 | |
| United States, Louisiana | |
| Novo Nordisk Investigational Site | |
| Slidell, Louisiana, United States, 70461-4231 | |
| United States, Montana | |
| Novo Nordisk Investigational Site | |
| Billings, Montana, United States, 59102 | |
| United States, New York | |
| Novo Nordisk Investigational Site | |
| Staten Island, New York, United States, 10301 | |
| United States, North Carolina | |
| Novo Nordisk Investigational Site | |
| Greensboro, North Carolina, United States, 27408 | |
| United States, Ohio | |
| Novo Nordisk Investigational Site | |
| Franklin, Ohio, United States, 45005 | |
| United States, Pennsylvania | |
| Novo Nordisk Investigational Site | |
| Melrose Park, Pennsylvania, United States, 19027 | |
| United States, Rhode Island | |
| Novo Nordisk Investigational Site | |
| East Providence, Rhode Island, United States, 02914 | |
| United States, Tennessee | |
| Novo Nordisk Investigational Site | |
| Humboldt, Tennessee, United States, 38343 | |
| United States, Texas | |
| Novo Nordisk Investigational Site | |
| Houston, Texas, United States, 77095 | |
| Novo Nordisk Investigational Site | |
| Killeen, Texas, United States, 76543-5600 | |
| Novo Nordisk Investigational Site | |
| San Antonio, Texas, United States, 78224 | |
| United States, Utah | |
| Novo Nordisk Investigational Site | |
| Ogden, Utah, United States, 84403 | |
| Novo Nordisk Investigational Site | |
| St. George, Utah, United States, 84790 | |
| Finland | |
| Novo Nordisk Investigational Site | |
| Helsinki, Finland, 00260 | |
| Novo Nordisk Investigational Site | |
| Kerava, Finland, FI-04200 | |
| Novo Nordisk Investigational Site | |
| Tampere, Finland, 33210 | |
| Novo Nordisk Investigational Site | |
| Turku, Finland, 20520 | |
| Novo Nordisk Investigational Site | |
| Turku, Finland, FI-20100 | |
| Germany | |
| Novo Nordisk Investigational Site | |
| Berlin, Germany, 12163 | |
| Novo Nordisk Investigational Site | |
| Friedrichsthal, Germany, 66299 | |
| Novo Nordisk Investigational Site | |
| Hohenmölsen, Germany, 06679 | |
| Novo Nordisk Investigational Site | |
| Münster, Germany, 48145 | |
| Novo Nordisk Investigational Site | |
| Neuwied, Germany, 56564 | |
| Novo Nordisk Investigational Site | |
| Völklingen, Germany, 66333 | |
| Spain | |
| Novo Nordisk Investigational Site | |
| Almería, Spain, 04001 | |
| Novo Nordisk Investigational Site | |
| Antequera, Spain, 29200 | |
| Novo Nordisk Investigational Site | |
| Gijón, Spain, 33206 | |
| Novo Nordisk Investigational Site | |
| Málaga, Spain, 29006 | |
| Novo Nordisk Investigational Site | |
| Palma de Mallorca, Spain, 07014 | |
| Novo Nordisk Investigational Site | |
| Palma de Mallorca, Spain, 07198 | |
| Novo Nordisk Investigational Site | |
| Pozuelo de Alarcon, Spain, 28223 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Publications of Results:
Publications of Results:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01326026 |
| Other Study ID Numbers: |
NN1250-3846 U1111-1117-0616 ( Other Identifier: WHO ) 2010-022337-29 ( EudraCT Number ) |
| First Posted: | March 30, 2011 Key Record Dates |
| Results First Posted: | November 17, 2015 |
| Last Update Posted: | March 6, 2017 |
| Last Verified: | January 2017 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Insulin, Globin Zinc Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs |