Srinagar: Advances in diabetes care are likely to improve life quality of diabetics in general and those desiring to observe Ramadhan fast. Major stride in this regard is the development of newer versions of insulin (designer insulin) or improvised methods of delivery. Commonly used are analogues of the insulin: ultra short acting analogues such as Lispro (Humalog), Aspart (Novorapid), etc. that have a very short duration of action and hence low chances of hypoglycemia (low sugar). These agents also don’t require any waiting before the meal and therefore, are called “shot and eat“ agents. Hence they are quiet appropriate for fasting diabetics.
Peakless insulin such as Glargine (Glaritus, Basalog, Lantus), Detmir (Levimer) or Degludec (Tresiba) are also suitable in combination with the above analogues or oral agents. These agents do not cause low glucose and also can be used in Ramadhan though judiciously.
Modes of insulin administration are going to significantly improve diabetes care in near future and it is going to greatly facilitate lives of diabetics desiring to observe Roza. On 29th June (the day of first Ramadhan) US Food and Drug Administration (FDA) approved rapid acting inhalational insulin (Afrezza) for its use in diabetes. It is good news for all diabetics. I visualize in near future it may be very useful in fasting diabetics. Afrezza, an insulin powder, comes in a single-use cartridge and is designed to be inhaled at the start of a meal or within 20 minutes. Therefore may be suitable for Ramadhan in combination with peakless insulin or oral agents.
Alfred E Mann, philanthropist and chief Executive of Mannkind, a California-based company that has no other products in the market, submitted the drug to FDA in March 2009 and it lost more than $191 million last year.
MannKind has said that patients using the drug can achieve peak insulin levels within 12 to 15 minutes. That compares to a wait time of an hour and a half or more after patients inject insulin. The agency is also requiring several follow-up studies looking at the drug’s long-term safety, including its impact on the heart and lungs.
It may be noted here that several other companies have failed to make inhaled insulin work commercially. In 2007, Pfizer Inc discontinued its inhaled insulin Exubera after it failed to gain ground in the market. In 2008, Eli Lilly & Co ended its development program, citing regulatory uncertainty.
In another major development, we are going to start an international trial on another newer molecule called Semaglutide that will have to be injected only once a week and in this trial it will be compared with Glargine insulin. The agent has shown promise in Phase-II trials and during the recent investigator meeting in Copenhagen Denmark where investigators from 32 participating countries met, the potential of its use in fasting diabetics was discussed. I led the Indian team of investigators in this meeting. We are likely to get DCGI approval in the month of September 2014 and the study will start as Ethics permissions have already been granted.
Conventionally there are many choices for patients with diabetes opting to observe the fast. All these agents have simplified the diabetes care but need to be discussed fully with patients. Oral agents like Metformin, Pioglitazone, Gliptins (Sitagliptin, Saxagliptin, Linagliptin and Vildagliptin) and alpha glycosidase inhibitors (Voglibose or Acarbose) are the first line choices provided diabetes is uncomplicated and is not so severe (high level of glucose). These agents can be given at any time (Iftar or Sehri) and do not cause hypoglycemia (low glucose).
Glimepiride and Gliclazide MR are the second line agents but their requirement of doses should be less than half maximal. Important precaution is that these agents can be used at the time of Iftar (evening meal) and patients have to be warned about hypoglycemia. A blood glucose level of 10 hours fast) should prompt to break the fast.
Among insulin users (mainly Type-1 diabetics), majority of subjects are advised to refrain from the fast especially if there is prevalent poor glucose control or history of frequent hypoglycemia, as has been exempted in the Holy Quran (Sura Bakra Verse 83:85). If the total insulin dose is approximately <30 units a day and patient is insisting on fasting, it is advisable to divide the insulin into two doses (premixed insulin generally) and administer two third before Iftar and 1/3rd before Sehri. It is needless to say fasting in diabetics is to be planned well before the arrival of Ramadhan and patient and physician should discuss the pros and cons after a fresh evaluation. Besides these caveats majority of subjects are able to fast without problems and in fact if properly guided derive multiple metabolic benefits by observing the fast.
(Author – Dr. Ashraf – is a Senior Consultant at the Department of Endocrinology, All India Institute of Medical Sciences (AIIMS), New Delhi)
Peakless insulin such as Glargine (Glaritus, Basalog, Lantus), Detmir (Levimer) or Degludec (Tresiba) are also suitable in combination with the above analogues or oral agents. These agents do not cause low glucose and also can be used in Ramadhan though judiciously.
Modes of insulin administration are going to significantly improve diabetes care in near future and it is going to greatly facilitate lives of diabetics desiring to observe Roza. On 29th June (the day of first Ramadhan) US Food and Drug Administration (FDA) approved rapid acting inhalational insulin (Afrezza) for its use in diabetes. It is good news for all diabetics. I visualize in near future it may be very useful in fasting diabetics. Afrezza, an insulin powder, comes in a single-use cartridge and is designed to be inhaled at the start of a meal or within 20 minutes. Therefore may be suitable for Ramadhan in combination with peakless insulin or oral agents.
Alfred E Mann, philanthropist and chief Executive of Mannkind, a California-based company that has no other products in the market, submitted the drug to FDA in March 2009 and it lost more than $191 million last year.
MannKind has said that patients using the drug can achieve peak insulin levels within 12 to 15 minutes. That compares to a wait time of an hour and a half or more after patients inject insulin. The agency is also requiring several follow-up studies looking at the drug’s long-term safety, including its impact on the heart and lungs.
It may be noted here that several other companies have failed to make inhaled insulin work commercially. In 2007, Pfizer Inc discontinued its inhaled insulin Exubera after it failed to gain ground in the market. In 2008, Eli Lilly & Co ended its development program, citing regulatory uncertainty.
In another major development, we are going to start an international trial on another newer molecule called Semaglutide that will have to be injected only once a week and in this trial it will be compared with Glargine insulin. The agent has shown promise in Phase-II trials and during the recent investigator meeting in Copenhagen Denmark where investigators from 32 participating countries met, the potential of its use in fasting diabetics was discussed. I led the Indian team of investigators in this meeting. We are likely to get DCGI approval in the month of September 2014 and the study will start as Ethics permissions have already been granted.
Conventionally there are many choices for patients with diabetes opting to observe the fast. All these agents have simplified the diabetes care but need to be discussed fully with patients. Oral agents like Metformin, Pioglitazone, Gliptins (Sitagliptin, Saxagliptin, Linagliptin and Vildagliptin) and alpha glycosidase inhibitors (Voglibose or Acarbose) are the first line choices provided diabetes is uncomplicated and is not so severe (high level of glucose). These agents can be given at any time (Iftar or Sehri) and do not cause hypoglycemia (low glucose).
Glimepiride and Gliclazide MR are the second line agents but their requirement of doses should be less than half maximal. Important precaution is that these agents can be used at the time of Iftar (evening meal) and patients have to be warned about hypoglycemia. A blood glucose level of 10 hours fast) should prompt to break the fast.
Among insulin users (mainly Type-1 diabetics), majority of subjects are advised to refrain from the fast especially if there is prevalent poor glucose control or history of frequent hypoglycemia, as has been exempted in the Holy Quran (Sura Bakra Verse 83:85). If the total insulin dose is approximately <30 units a day and patient is insisting on fasting, it is advisable to divide the insulin into two doses (premixed insulin generally) and administer two third before Iftar and 1/3rd before Sehri. It is needless to say fasting in diabetics is to be planned well before the arrival of Ramadhan and patient and physician should discuss the pros and cons after a fresh evaluation. Besides these caveats majority of subjects are able to fast without problems and in fact if properly guided derive multiple metabolic benefits by observing the fast.
(Author – Dr. Ashraf – is a Senior Consultant at the Department of Endocrinology, All India Institute of Medical Sciences (AIIMS), New Delhi)
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