BIRMINGHAM, AL, March 02, 2013 (Press-News.org) *Achieve Clinical Research conducts Clinical Trials in Birmingham, Alabama. For more information about getting started with a Diabetes Clinical Trial, please visit our website or contact us directly at (205) 380-6434
BACKGROUND AND RATIONALE
Type 2 diabetes mellitus (T2DM) is a multi-organ disease characterized by defective insulin action in the liver, adipose tissue and skeletal muscle and a relative impairment of insulin secretion capacity. At diagnosis, subjects with T2DM have only 50% of their beta-cell function remaining and with progressing disease patients become profoundly insulin deficient requiring insulin therapy to restore glycaemic control.
In addition, a blunted secretion and/or action of incretin hormones glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP) from the gastro-intestinal tract in response to a meal are also characteristic of T2DM. GLP-1 is an important postprandial hormone secreted from the L-cells in the intestine with a stimulating effect on insulin secretion and an inhibitory role on glucagon secretion from the endocrine pancreas in a glucose-dependent manner.
You can also read more diabetes news at our blog.
PRIMARY OBJECTIVE
To confirm superiority of insulin degludec/liraglutide versus unchanged GLP-1 receptor agonist therapy in controlling glycaemia in insulin naive subjects with T2DM inadequately controlled on GLP-1 receptor agonist therapy in combination with metformin±pioglitazone±sulphonylurea.
SECONDARY OBJECTIVE
To compare general efficacy and safety of insulin degludec/liraglutide versus unchanged GLP-1 receptor agonist therapy in insulin naive subjects with T2DM inadequately controlled with GLP-1 receptor agonist therapy in combination with metformin±pioglitazone±sulphonylurea after 26 weeks of treatment.
INCLUSION CRITERIA
1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
2. Type 2 diabetes mellitus
3. Male or female over 18 years of age
4. HbAlc 7.0-9.0% (53-75 mmol/mol) (both inclusive)
5. Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg OD Victoza (liraglutide) or 10 microgram BID Byetta (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza (liraglutide) or 5 microgram BID Byetta (exenatide)) in combination with a stable daily dose of metformin (more than 1500 mg or documented maximum tolerated dose) ± stable daily dose of pioglitazone (more than30 mg) ±stable daily dose of sulphonylurea (more than half of the max approved dose according to local label) more than 90 days prior to screening visit (Visit 1)
6. BMI less than 40 kg/m^
7. Able and willing to adhere to the protocol including performing self measured plasma glucose profiles, to keep a trial diary and to use pre-filled pen device
For information about how to participate in this type 2 diabetes clinical trial, visit Achieve Clinical Research or contact us directly at (205) 380-6434
Type 2 Diabetes Clinical Trial Now Enrolling at Achieve Clinical Research in Birmingham, Alabama; Accepting M/F Age 18+ with Type 2 Diabetes
A 26-week, multi-center, multinational, open-label, 2-arm parallel, randomized, treat-to-target trial in insulin naive subjects with Type 2 Diabetes.
2013-03-02
ELSE PRESS RELEASES FROM THIS DATE:
Grauer School 6th Grade Student Exemplifies Impact of Small Schools Movement
2013-03-02
Alexandra Parker is a 6th grade student that represents the qualities inspired by the nationally growing small-schools educational model. Alexandra's outstanding accomplishments epitomize the potential that the Grauer School in Encinitas is renowned for cultivating and that results in an increasing record number of unsolicited merit scholarships offered to Grauer graduates annually. Encompassing the core of the small schools movement (personalized, all-inclusive, self-goverened schools serving no more than 350 students), the successful technique has motivated Alexandra ...
Domusstudio Architecture Completes Greenhouse-Inspired Fire Station #2 in Encinitas
2013-03-02
Local flower fields and greenhouses inspired the design for Encinitas Fire Station #2, which was unveiled to the public on Feb. 22 and has been serving the community since early January. Located at 618 Birmingham Dr. in Encinitas, the facility designed by San Diego firm domusstudio architecture replaced the outdated Fire Station #2 building.
The new fire station is highly visible along Interstate 5 in Encinitas, and is located just east of the previous station site.
According to domusstudio architect Wayne Holtan, the single-story, 6,330 square-foot building—with ...
Julienne Johnson Unveils New Exhibition at LA Artcore Brewery Annex March 3rd - 30th, 2013
2013-03-02
Julienne Johnson's latest body of work continues her exploration of communication and connectivity through her mixed media paintings on exhibit at LA Artcore - Brewery Annex, March 3 - 30, 2013. The opening reception and conversation with the artist will commence on Sunday, March 3rd. Johnson has coordinated a closing reception and poetry reading: SPOKEn WORD & PAINT, featuring acclaimed writers, Peter Frank (international art critic, curator, poet) and Jack Grapes (award winning poet, playwright, actor, teacher). The poetry reading will coincide with the closing of ...
DCS Industries, LLC Announces the CAL Double Bolt Lock to Product Line
2013-03-02
DCS Industries, LLC in Phoenix, AZ is proud to announce the addition of CAL Double Bolt Locks to their selection of home and pool safety products. According to the manufacturer, "The CAL Double-Bolt Lock works by securing the door to the frame at two security points and preventing any movement of the door. With its double locking action the CAL Double-Bolt Lock makes it virtually impossible to remove the door by lifting it off its track."
DCS Industries is currently offering a discounted price on purchase and installation of the CAL Double-Bolt Lock. Normally ...
Journey Bar Shakes Up Their Savory Bars
2013-03-02
Savory bars offer the flavor variety and lower-sugar options consumers are demanding in their nutrition bars
Journey Bar shook up the bar aisle in 2012 when it broke away from the typical sweet nutrition bar flavors and launched its line savory flavored bars. Now, Journey Bar is excited to announce significant changes to their product line, including: new flavors, a new softer and chewier texture, and more protein! Additionally, Journey Bars are now all vegan and gluten-free. Journey Bar is set to debut their new and improved line at Natural Products Expo West in Anaheim, ...
Apricot Lane Expansion Planned for Charlotte
2013-03-02
Apricot Lane, a popular national boutique featuring celebrity-inspired affordable fashions for the everyday woman, is expanding its footprint in the Southeast with three stores planned for the Charlotte market. The chain, which operates under the franchise company Country Visions and has its corporate office in California, previously had one store in the area, located in Huntersville's Birkdale Village. That store closed in early February and was revamped under new ownership. It will officially reopen by this Friday, March 1.
All visitors to the new Huntersville store ...
greeNEWit Co-Founder and Social Entrepreneur Speaks at University of Maryland's Fifth Annual Social Enterprise Symposium
2013-03-02
Social entrepreneurs are individuals with innovative solutions to societyâEUR s most pressing social problems. What does it take to be one, and what are the challenges? Students from the Robert H. Smith School of Business at the University of Maryland will have the opportunity to ask greeNEWit Co-Founder Josh Notes at the Creating Value Social Enterprise Symposium on March 1, 2013 at the Stamp Student Union.
Notes is one of five social entrepreneurs who are tackling issues ranging from education to the environment. He will be leading the "Storytellers: From the ...
TharpeRobbins Receives Safe Harbor Privacy Compliance from U.S. Department of Commerce
2013-03-02
The TharpeRobbins Company, a global leader in managed employee rewards and recognition, recently completed the U.S. Department of Commerce's Safe Harbor privacy protection certification process.
Safe Harbor certification is a program developed by the U.S. Department of Commerce in consultation with the European Commission to assist U.S. companies in complying with the European Union's Directive on Data Protection. Requiring adherence to seven key principles relating to data access, transfer and security, certification provides the public with an assurance that participating ...
Melanic Tees Debuts New Tee's for Spring Tribal Coolection 2013
2013-03-02
Melanic Tees debuts New Tee's for Spring Tribal Coolection 2013
Los Angeles, CALI Native Annae Padilla aka Api creator of Melanic Tees Coolection will be debuting her New Tees for her Coolection of Cool, Feminine Tees featuring fluency, tribal designs and Indigenous patterns. "I was inspired to do a Tee line specifically for Women&girls of color because I feel there is a definite absence of Models Keen to Native, Indigenous Melaninated People. I am very conscious of the Fashion World that uses "tribal or native" designs for seasonal or recreational ...
New Music Reality Show Will Showcase Unsigned Acts and "Hit" Song Remakes.
2013-03-02
Cover Me is a "Behind the Music" series based in Austin, Texas. It will feature a group of musicians and singers collectively known as "The Cover Kings". The show is currently running a campaign on Kickstarter.com.
This musical biography will explore some of the the greatest hit songs of our time and the artists that made them famous. Cover Me will examine some 90 iconic artists ranging from ABBA to ZZ Top, relate the story of the song and the artist - and then create a modern interpretation of the material. Combining new music technology and Austin's ...
LAST 30 PRESS RELEASES:
GP-led talking therapy eases PTSD symptoms after critical illness
Removing ovaries and fallopian tubes linked to lower risk of early death among breast cancer patients with BRCA cancer genes
The Lancet: Nearly half of sexual abuse first happens at age 15 or younger
Satellites observe glacier committing “ice piracy”
Non-inherited genes affect children’s development
Social media platform tailoring could support more fulfilling use, study finds
The hope for detecting Parkinson’s disease much earlier with a simple brain scan
MRI breakthrough could revolutionize diagnosis of common heart problem aortic stenosis
Enhanced CAR T cell therapy offers new strategy for lymphoma
Researchers identify measure of pulse rate that can predict faster cognitive decline in older adults
Discovery of dopamine receptors in a previously overlooked part of the brain sheds light on the complex circuitry for anxiety and depression
No one to play with? UCLA’s PEERS for Preschoolers program is changing that
New method provides fresh insights into insect decline
Foot traffic can predict COVID-19 spread in New York City neighborhoods
Janice R. Lachance, J.D., FASAE selected for top position of global earth and space science association
Eating ultra processed foods may speed up early signs of Parkinson's disease
Sleep apnea during REM sleep linked to memory-related brain changes
Vaccines of the future: harnessing the immune system for long-lasting protection
GigaScience Press wins inaugural Crossref Metadata Award for highest quality publishing metadata standards for their journal GigaByte
Eating disorders: The hidden health crisis on college campuses
New study reveals striking differences in life expectancy across U.S. states
Global study finds political left more trusting of climate scientists than right
New discovery shows how molecules can mute heat like music
Dementia rates in China are rising disproportionately
India has one of the world’s highest densities of snow leopards
Although our general tendency to be curious may decrease with age, our situational or "state" curiosity might actually increase across the lifespan, which might help boost well-being and cognitive out
People displaying high problematic (excessive and dependent) social media use are more likely to engage with and believe fake news
Better physical health probably follows religious and spiritual engagement, rather than vice versa, per six year longitudinal US study aiming to tease out this relationship
Excess weight, including overweight and obesity, is linked with experiencing Long COVID neurological symptoms including headaches, vertigo, sleep problems and depression, per meta-analysis of studies
Are you curious? It might help you stay sharp as you age
[Press-News.org] Type 2 Diabetes Clinical Trial Now Enrolling at Achieve Clinical Research in Birmingham, Alabama; Accepting M/F Age 18+ with Type 2 DiabetesA 26-week, multi-center, multinational, open-label, 2-arm parallel, randomized, treat-to-target trial in insulin naive subjects with Type 2 Diabetes.